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# Data provenance — regulatory-affairs-manager
Where the content of this skill package comes from, counted by
content items (tasks, competences, tools, evidence entries, curated
knowledge). Rendered live by Gitea:
```mermaid
%%{init: {'theme':'base','themeVariables':{'pie1':'#f9a825','pie2':'#1e88e5','pie3':'#ff355e','pie4':'#d97757','pie5':'#8e24aa','pieOuterStrokeWidth':'0px','pieSectionTextColor':'#fff'}}}%%
pie showData
title Content sources — regulatory-affairs-manager
"ESCO (occupation & competences)" : 52
"O*NET (tasks & tools)" : 123
"Job boards (market evidence)" : 100
"Anthropic official Claude skills" : 5
"External AI skill packs (mapped)" : 153
```
| Source | Items | Share | Files |
|---|---|---|---|
| ESCO (occupation & competences) | 52 | 12.0 % | references/profile.md, references/skills.md |
| O*NET (tasks & tools) | 123 | 28.4 % | references/tasks.md, references/tools.md |
| Job boards (market evidence) | 100 | 23.1 % | references/market.md (full report) + "Market evidence" headline sections |
| Wikipedia & AI expert curation | 0 | 0.0 % | glossary, literature, usecases, intake, quality, evals/ |
| Anthropic official Claude skills | 5 | 1.2 % | references/ai-skills.md, section "anthropics/skills" (official Claude Code skills) |
| External AI skill packs (mapped) | 153 | 35.3 % | references/ai-skills.md (per-source attribution inside) |
| Stack Exchange practitioner Q&A (CC-BY-SA) | 0 | 0.0 % | references/practitioner-qa.md (per-entry attribution inside) |
Licensing: O*NET (USDOL/ETA, CC BY 4.0) · ESCO (© European Union) ·
job-ad evidence via official APIs (JSearch/Adzuna) · Wikipedia content
paraphrased with source URLs — never copied · external AI skills are
linked, not copied (Apache-2.0/MIT/source-available, see ai-skills.md).

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---
name: regulatory-affairs-manager
description: "Occupational skill for the role 'regulatory affairs manager' (also: compliance manager, regulatory manager, bank compliance officer, regulatory compliance officer, regulatory affairs specialist, regulatory affairs officer). Use when the user asks for typical regulatory affairs manager work such as: Direct the preparation and submission of regulatory agency applications, reports, or correspondence.; Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.; Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products."
---
# Regulatory Affairs Manager
Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.
## Core workflow
1. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
2. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
3. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
4. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
5. Develop regulatory strategies and implementation plans for the preparation and submission of new products.
6. Establish regulatory priorities or budgets and allocate resources and workloads.
7. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
8. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
## How to use this skill
- Read [references/profile.md](references/profile.md) for the occupation profile and scope.
- Consult [references/tasks.md](references/tasks.md) for the full task and activity inventory.
- Check [references/skills.md](references/skills.md) for essential vs. optional competences.
- Check [references/tools.md](references/tools.md) for the software commonly used in this role.
- See [references/ai-skills.md](references/ai-skills.md) — matched external AI agent skills (per-source attribution).
## Key competences (essential)
- advise on efficiency improvements
- analyse legislation
- business analysis
- company policies
- comply with legal regulations
- corporate sustainability
- develop company strategies
- develop licensing agreements
- develop organisational policies
- enforce financial policies
- ensure compliance with company regulations
- ensure compliance with legal requirements
- ensure compliance with policies
- ensure products meet regulatory requirements
- identify legal requirements
## Hot technologies
- Tableau
- Microsoft Access
- Structured query language SQL
- Adobe Acrobat
- Microsoft SharePoint
- Microsoft Outlook
- SAP software
- Microsoft Office software
- Microsoft Windows
- Microsoft PowerPoint
<!-- hot-tech -->
## Hot technologies
Top tools from 53 gated job ads (see references/market.md, as of 2026-07-19):
- Microsoft Office — 17 %
- Adobe Acrobat — 6 %
- Smartsheet — 6 %
<!-- hot-tech -->
---
*Sources: ESCO v1.2.1 (http://data.europa.eu/esco/occupation/779d13be-60b4-48f3-a339-fe483be96c7f), O*NET 30.3 (11-9199.01). See manifest.json for licensing/attribution.*

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{
"name": "regulatory-affairs-manager",
"title": "regulatory affairs manager",
"version": "0.1.0",
"layer": "core",
"language": "en",
"generated": "2026-07-07",
"ids": {
"esco_uri": "http://data.europa.eu/esco/occupation/779d13be-60b4-48f3-a339-fe483be96c7f",
"esco_code": "2619.12",
"isco_group": "2619",
"onet_soc": "11-9199.01",
"crosswalk_match": "exactMatch"
},
"sources": [
{
"name": "ESCO",
"version": "1.2.1",
"url": "https://esco.ec.europa.eu/"
},
{
"name": "O*NET",
"version": "30.3",
"url": "https://www.onetcenter.org/",
"license": "CC BY 4.0"
}
],
"attribution": "This package includes information from the O*NET Database (v30.3) by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), CC BY 4.0. skillfactor is not endorsed by USDOL/ETA. ESCO data (v1.2.1) (c) European Union, used per the ESCO download conditions: https://esco.ec.europa.eu/en/use-esco/download",
"counts": {
"tasks": 27,
"dwas": 28,
"skills_essential": 26,
"skills_optional": 25,
"software": 67
},
"enrichment_ai_skills": {
"generated": "2026-07-14",
"method": "deterministic mapping (ISCO prefix + title/competence keywords)",
"sources": {
"anthropics/skills": {
"repo": "https://github.com/anthropics/skills",
"commit": "f6656c1",
"license": "Apache-2.0; the document skills (docx/pdf/pptx/xlsx) are source-available \u2014 see the LICENSE.txt in the upstream skill folder",
"skills": 2
},
"wshobson/agents": {
"repo": "https://github.com/wshobson/agents",
"commit": "6fd3247",
"license": "MIT (c) Seth Hobson",
"skills": 2
},
"vibeeval/vibecosystem": {
"repo": "https://github.com/vibeeval/vibecosystem",
"commit": "cea9462",
"license": "MIT",
"skills": 5
},
"brycewang-stanford/Auto-Empirical-Research-Skills": {
"repo": "https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills",
"commit": "85bf545",
"license": "CC-BY-4.0",
"skills": 5
},
"zebbern/claude-code-guide": {
"repo": "https://github.com/zebbern/claude-code-guide",
"commit": "d2c5280",
"license": "MIT",
"skills": 1
},
"a5c-ai/babysitter": {
"repo": "https://github.com/a5c-ai/babysitter",
"commit": "44a5d58b",
"license": "MIT",
"skills": 12
},
"jeremylongshore/claude-code-plugins-plus-skills": {
"repo": "https://github.com/jeremylongshore/claude-code-plugins-plus-skills",
"commit": "e112938a",
"license": "MIT",
"skills": 12
},
"open-gitagent/opengap": {
"repo": "https://github.com/open-gitagent/opengap",
"commit": "d7a8e2e",
"license": "MIT",
"skills": 1
},
"davila7/claude-code-templates": {
"repo": "https://github.com/davila7/claude-code-templates",
"commit": "fa79251",
"license": "MIT",
"skills": 4
},
"kazukinagata/shinkoku": {
"repo": "https://github.com/kazukinagata/shinkoku",
"commit": "e610b30",
"license": "MIT",
"skills": 2
},
"alirezarezvani/claude-skills": {
"repo": "https://github.com/alirezarezvani/claude-skills",
"commit": "0241f43",
"license": "MIT",
"skills": 4
},
"Sushegaad/Claude-Skills-Governance-Risk-and-Compliance": {
"repo": "https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance",
"commit": "71d8920",
"license": "MIT",
"skills": 3
},
"mukul975/Anthropic-Cybersecurity-Skills": {
"repo": "https://github.com/mukul975/Anthropic-Cybersecurity-Skills",
"commit": "673da1f",
"license": "Apache-2.0",
"skills": 8
},
"nexscope-ai/eCommerce-Skills": {
"repo": "https://github.com/nexscope-ai/eCommerce-Skills",
"commit": "56f3288",
"license": "MIT",
"skills": 3
},
"ruvnet/claude-code-flow": {
"repo": "https://github.com/ruvnet/claude-code-flow",
"commit": "73914bd",
"license": "MIT",
"skills": 1
},
"ruvnet/ruflo": {
"repo": "https://github.com/ruvnet/ruflo",
"commit": "73914bd",
"license": "MIT",
"skills": 1
},
"mohitagw15856/pm-claude-skills": {
"repo": "https://github.com/mohitagw15856/pm-claude-skills",
"commit": "876fa30",
"license": "MIT",
"skills": 3
},
"samber/cc-skills-golang": {
"repo": "https://github.com/samber/cc-skills-golang",
"commit": "4881c01",
"license": "MIT",
"skills": 1
},
"affaan-m/everything-claude-code": {
"repo": "https://github.com/affaan-m/everything-claude-code",
"commit": "ed38744",
"license": "MIT",
"skills": 2
},
"ahacker-1/cre-agent-skills": {
"repo": "https://github.com/ahacker-1/cre-agent-skills",
"commit": "618734e",
"license": "Apache-2.0",
"skills": 1
},
"aaron-he-zhu/aaron-marketing-skills": {
"repo": "https://github.com/aaron-he-zhu/aaron-marketing-skills",
"commit": "b7b0b9f",
"license": "Apache-2.0",
"skills": 1
},
"davepoon/buildwithclaude": {
"repo": "https://github.com/davepoon/buildwithclaude",
"commit": "3c94e0c",
"license": "MIT",
"skills": 2
},
"syahiidkamil/Software-Engineer-AI-Agent-Atlas": {
"repo": "https://github.com/syahiidkamil/Software-Engineer-AI-Agent-Atlas",
"commit": "fc0bf11",
"license": "no explicit license \u2014 referenced by link only",
"skills": 1
},
"HeshamFS/materials-simulation-skills": {
"repo": "https://github.com/HeshamFS/materials-simulation-skills",
"commit": "fa1ce8d",
"license": "Apache-2.0",
"skills": 1
},
"infrasity-labs/dev-gtm-claude-skills": {
"repo": "https://github.com/infrasity-labs/dev-gtm-claude-skills",
"commit": "02cfefb",
"license": "MIT",
"skills": 1
},
"AgriciDaniel/claude-seo": {
"repo": "https://github.com/AgriciDaniel/claude-seo",
"commit": "6cf1ea9",
"license": "MIT",
"skills": 1
}
},
"total_skills": 80,
"tiers": {
"core": 77,
"adjacent": 3
}
},
"provenance": {
"items": {
"esco": 52,
"onet": 123,
"jobads": 100,
"wiki_ai": 0,
"anthropic": 5,
"ai_skills": 153,
"stackx": 0
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"share_percent": {
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"onet": 28.4,
"jobads": 23.1,
"wiki_ai": 0.0,
"anthropic": 1.2,
"ai_skills": 35.3,
"stackx": 0.0
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"method": "content items per source category"
},
"collar": "white",
"computer_work": true
}

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# External AI agent skills — regulatory-affairs-manager
Proven, publicly available AI agent skills mapped to this occupation.
Nothing is copied from the sources: every entry is a name, a one-line
summary and a link to the upstream skill package. Each section names
its source repository, commit, license and retrieval date.
**Tiers:** `core` = the skill directly exercises a top market hard
skill, tool or method (from gated job-ad evidence) or an essential
ESCO competence of this occupation; `adjacent` =
plausibly useful, secondary. Entries are capped at 12 per source
and 80 in total per occupation (core first,
strongest matches survive); everything beyond the caps is excluded
and logged in the pipeline audit trail, not in this package.
_Matched deterministically (ISCO group + title/competence keywords,
tiered against market evidence + ESCO essentials) by
`pipeline/p5_enrich_ai_skills.py` on 2026-07-14._
## Source: anthropics/skills
- Repository: [https://github.com/anthropics/skills](https://github.com/anthropics/skills) (commit `f6656c1`, retrieved 2026-07-14)
- License: Apache-2.0; the document skills (docx/pdf/pptx/xlsx) are source-available — see the LICENSE.txt in the upstream skill folder
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `docx` | adjacent | Use this skill whenever the user wants to create, read, edit, or manipulate Word documents (.docx files) or Word templates (.dotx files). Triggers include: any mention of 'Word doc', 'word document', '.docx', '.dotx', or requests to … | [source](https://github.com/anthropics/skills/tree/main/skills/docx) |
| `pdf` | adjacent | Use this skill whenever the user wants to do anything with PDF files. This includes reading or extracting text/tables from PDFs, combining or merging multiple PDFs into one, splitting PDFs apart, rotating pages, adding watermarks, creating … | [source](https://github.com/anthropics/skills/tree/main/skills/pdf) |
## Source: wshobson/agents
- Repository: [https://github.com/wshobson/agents](https://github.com/wshobson/agents) (commit `6fd3247`, retrieved 2026-07-14)
- License: MIT (c) Seth Hobson
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `gdpr-data-handling` | core | Implement GDPR-compliant data handling with consent management, data subject rights, and privacy by design. Use when building systems that process EU personal data, implementing privacy controls, or conducting GDPR compliance reviews. | [source](https://github.com/wshobson/agents/tree/main/plugins/hr-legal-compliance/skills/gdpr-data-handling) |
| `employment-contract-templates` | adjacent | Create employment contracts, offer letters, and HR policy documents following legal best practices. Use when drafting employment agreements, creating HR policies, or standardizing employment documentation. | [source](https://github.com/wshobson/agents/tree/main/plugins/hr-legal-compliance/skills/employment-contract-templates) |
## Source: a5c-ai/babysitter
- Repository: [https://github.com/a5c-ai/babysitter](https://github.com/a5c-ai/babysitter) (commit `44a5d58b`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `regulatory-compliance-assessment` | core | Evaluate organizational compliance with healthcare regulations including HIPAA, CMS Conditions of Participation, and accreditation standards through gap analysis and audit procedures | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/social-sciences-humanities/healthcare/skills/regulatory-compliance-assessment) |
| `iso-nanotechnology-compliance-checker` | core | Regulatory compliance skill for ISO nanotechnology standards verification and documentation | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/science/nanotechnology/skills/iso-nanotechnology-compliance-checker) |
| `policy-management` | core | Manage corporate policy lifecycle from drafting through compliance | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/business/legal/skills/policy-management) |
| `cultural-policy-analysis` | core | Analyze cultural policies, assess community cultural needs, and develop evidence-based recommendations for arts funding and cultural development | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/social-sciences-humanities/arts-culture/skills/cultural-policy-analysis) |
| `gdpr-compliance-automator` | core | GDPR compliance assessment and automation for data mapping, consent management, DSAR handling, and privacy impact assessments | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/security-compliance/skills/gdpr-compliance-automator) |
| `license-compliance-checker` | core | Automated license compliance verification for dependencies to ensure legal compliance during migration | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/code-migration-modernization/skills/license-compliance-checker) |
| `capacity-planner` | core | Capacity requirements planning skill with demand-capacity gap analysis and capacity strategy recommendations | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/business/operations/skills/capacity-planner) |
| `bug-bounty` | core | Bug bounty program management and security disclosure expertise for smart contracts. Covers program setup on Immunefi, vulnerability triage, responsible disclosure coordination, bounty payments, and post-disclosure analysis. | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/cryptography-blockchain/skills/bug-bounty) |
| `echidna-fuzzer` | core | Property-based testing and fuzzing using Echidna for smart contracts. Includes invariant definition, corpus management, coverage analysis, and CI/CD integration for comprehensive security testing. | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/cryptography-blockchain/skills/echidna-fuzzer) |
| `entity-management` | core | Track and manage subsidiary and entity information | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/business/legal/skills/entity-management) |
| `interview-questions` | core | Generate competency-based and behavioral interview questions with legal compliance validation | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/domains/business/human-resources/skills/interview-questions) |
| `translation-management` | core | Integration with translation management systems and i18n workflows. Connect with Crowdin, Transifex, Weblate, manage translation memory, synchronize glossaries, and automate localization pipelines. | [source](https://github.com/a5c-ai/babysitter/tree/44a5d58b/library/specializations/technical-documentation/skills/translation-management) |
## Source: aaron-he-zhu/aaron-marketing-skills
- Repository: [https://github.com/aaron-he-zhu/aaron-marketing-skills](https://github.com/aaron-he-zhu/aaron-marketing-skills) (commit `b7b0b9f`, retrieved 2026-07-14)
- License: Apache-2.0
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `memory-management` | core | Use when the user asks to "remember project context", review saved findings, initialize runtime memory, archive stale work, reconcile notes, or erase a subject; manages authorized HOT/WARM/COLD working memory across all disciplines while … | [source](https://github.com/aaron-he-zhu/aaron-marketing-skills/tree/b7b0b9f/protocol/memory-management) |
## Source: affaan-m/everything-claude-code
- Repository: [https://github.com/affaan-m/everything-claude-code](https://github.com/affaan-m/everything-claude-code) (commit `ed38744`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `agentic-os` | core | Build persistent multi-agent operating systems on Claude Code. Covers kernel architecture, specialist agents, slash commands, file-based memory, scheduled automation, and state management without external databases. | [source](https://github.com/affaan-m/everything-claude-code/tree/ed38744/skills/agentic-os) |
| `competitive-report-structure` | core | Use after benchmark-methodology has produced scored competitor profile cards. Assembles findings into a decision-grade report: landscape map, competitor profiles, benchmarking matrix, white-space analysis, strategic recommendations, and … | [source](https://github.com/affaan-m/everything-claude-code/tree/ed38744/.agents/skills/competitive-report-structure) |
## Source: AgriciDaniel/claude-seo
- Repository: [https://github.com/AgriciDaniel/claude-seo](https://github.com/AgriciDaniel/claude-seo) (commit `6cf1ea9`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `seo-local` | core | Local SEO analysis covering Google Business Profile optimization, NAP consistency, citation health, review signals, local schema markup, location page quality, multi-location SEO, and industry-specific recommendations. Detects business … | [source](https://github.com/AgriciDaniel/claude-seo/tree/6cf1ea9/skills/seo-local) |
## Source: ahacker-1/cre-agent-skills
- Repository: [https://github.com/ahacker-1/cre-agent-skills](https://github.com/ahacker-1/cre-agent-skills) (commit `618734e`, retrieved 2026-07-14)
- License: Apache-2.0
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `cre-legal` | core | CRE Legal review suite — 6 specialist skills for PSA review, title & survey analysis, estoppel tracking, loan document review, insurance coordination, and transfer document preparation for multifamily acquisitions. | [source](https://github.com/ahacker-1/cre-agent-skills/tree/618734e/claude-code-plugins/cre-legal) |
## Source: alirezarezvani/claude-skills
- Repository: [https://github.com/alirezarezvani/claude-skills](https://github.com/alirezarezvani/claude-skills) (commit `0241f43`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `ceo-advisor` | core | Executive leadership guidance for strategic decision-making, organizational development, and stakeholder management. Use when planning strategy, preparing board presentations, managing investors, developing organizational culture, making … | [source](https://github.com/alirezarezvani/claude-skills/tree/0241f43/c-level-advisor/skills/ceo-advisor) |
| `iso42001-specialist` | core | ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses 4-10 and what do we close first? (2) What goes in the AI risk register and … | [source](https://github.com/alirezarezvani/claude-skills/tree/0241f43/ra-qm-team/compliance-team-iso42001/skills/iso42001-specialist) |
| `general-counsel-advisor` | core | General Counsel advisory for startups: contract review (MSA, SaaS, NDA, DPA, employment), IP strategy, term sheet decoding, and regulatory landscape mapping. Use when reviewing any contract or term sheet, deciding when to engage outside … | [source](https://github.com/alirezarezvani/claude-skills/tree/0241f43/c-level-advisor/general-counsel-advisor/skills/general-counsel-advisor) |
| `social-media-manager` | core | When the user wants to develop social media strategy, plan content calendars, manage community engagement, or grow their social presence across platforms. Also use when the user mentions 'social media strategy,' 'social calendar,' … | [source](https://github.com/alirezarezvani/claude-skills/tree/0241f43/marketing-skill/skills/social-media-manager) |
## Source: brycewang-stanford/Auto-Empirical-Research-Skills
- Repository: [https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills) (commit `85bf545`, retrieved 2026-07-14)
- License: CC-BY-4.0
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `law-skills` | core | 9 legal research skills. Trigger: legal research, case law analysis, regulatory compliance. Design: legal databases, citation networks, and judicial analytics tools. | [source](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills/tree/85bf545/skills/43-wentorai-research-plugins/skills/domains/law) |
| `legal-research-guide` | core | Legal research methods, case law analysis, and compliance tools | [source](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills/tree/85bf545/skills/43-wentorai-research-plugins/skills/domains/law/legal-research-guide) |
| `hud` | core | Diverga HUD (Heads-Up Display) management skill. Configure and manage the research project statusline display. Supports multiple presets: research, checkpoint, memory, minimal. Triggers: "hud", "statusline", "display settings | [source](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills/tree/85bf545/skills/25-HosungYou-Diverga/skills/hud) |
| `opencontracts-guide` | core | Legal document annotation, versioning, and analysis platform | [source](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills/tree/85bf545/skills/43-wentorai-research-plugins/skills/domains/law/opencontracts-guide) |
| `legal-nlp-guide` | core | NLP techniques for legal text analysis, case law mining, and contracts | [source](https://github.com/brycewang-stanford/Auto-Empirical-Research-Skills/tree/85bf545/skills/43-wentorai-research-plugins/skills/domains/law/legal-nlp-guide) |
## Source: davepoon/buildwithclaude
- Repository: [https://github.com/davepoon/buildwithclaude](https://github.com/davepoon/buildwithclaude) (commit `3c94e0c`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `monday-automation` | core | Automate Monday.com work management including boards, items, columns, groups, subitems, and updates via Rube MCP (Composio). Always search tools first for current schemas. | [source](https://github.com/davepoon/buildwithclaude/tree/3c94e0c/plugins/all-skills/skills/monday-automation) |
| `envelope-team` | core | Design and generate .envelope.json AI agent team definitions — the open standard for multi-agent teams with hierarchy, access policies, human-in-the-loop gates, and cron schedules. | [source](https://github.com/davepoon/buildwithclaude/tree/3c94e0c/plugins/all-skills/skills/envelope-team) |
## Source: davila7/claude-code-templates
- Repository: [https://github.com/davila7/claude-code-templates](https://github.com/davila7/claude-code-templates) (commit `fa79251`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `Data Privacy Compliance` | core | Data privacy and regulatory compliance specialist for GDPR, CCPA, HIPAA, and international data protection laws. Use when implementing privacy controls, conducting data protection impact assessments, ensuring regulatory compliance, or … | [source](https://github.com/davila7/claude-code-templates/tree/fa79251/cli-tool/components/skills/enterprise-communication/data-privacy-compliance) |
| `lint-and-validate` | core | Automatic quality control, linting, and static analysis procedures. Use after every code modification to ensure syntax correctness and project standards. Triggers onKeywords: lint, format, check, validate, types, static analysis. | [source](https://github.com/davila7/claude-code-templates/tree/fa79251/cli-tool/components/skills/development/lint-and-validate) |
| `microservices-patterns` | core | Master microservices architecture patterns including service boundaries, inter-service communication, data management, and resilience patterns for building distributed systems. | [source](https://github.com/davila7/claude-code-templates/tree/fa79251/cli-tool/components/skills/development/microservices-patterns) |
| `google-cloud-waf-reliability` | core | Generates reliability-focused guidance for Google Cloud workloads based on the Google Cloud Well-Architected Framework. Use to evaluate a workload, identify reliability requirements, and provide actionable recommendations for building … | [source](https://github.com/davila7/claude-code-templates/tree/fa79251/cli-tool/components/skills/development/google-cloud-waf-reliability) |
## Source: HeshamFS/materials-simulation-skills
- Repository: [https://github.com/HeshamFS/materials-simulation-skills](https://github.com/HeshamFS/materials-simulation-skills) (commit `fa1ce8d`, retrieved 2026-07-14)
- License: Apache-2.0
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `performance-profiling` | core | Identify computational bottlenecks, analyze parallel scaling, estimate memory requirements, and generate optimization recommendations for materials simulations — parse timing logs to find dominant phases (solver, assembly, I/O), evaluate … | [source](https://github.com/HeshamFS/materials-simulation-skills/tree/fa1ce8d/skills/simulation-workflow/performance-profiling) |
## Source: infrasity-labs/dev-gtm-claude-skills
- Repository: [https://github.com/infrasity-labs/dev-gtm-claude-skills](https://github.com/infrasity-labs/dev-gtm-claude-skills) (commit `02cfefb`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `seo-local` | core | Local SEO analysis covering Google Business Profile optimization, NAP consistency, citation health, review signals, local schema markup, location page quality, multi-location SEO, and industry-specific recommendations. Detects business … | [source](https://github.com/infrasity-labs/dev-gtm-claude-skills/tree/02cfefb/.claude/skills/seo-local) |
## Source: jeremylongshore/claude-code-plugins-plus-skills
- Repository: [https://github.com/jeremylongshore/claude-code-plugins-plus-skills](https://github.com/jeremylongshore/claude-code-plugins-plus-skills) (commit `e112938a`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `clay-data-handling` | core | Implement GDPR/CCPA-compliant data handling for Clay enrichment pipelines. Use when handling PII from enrichments, implementing data retention policies, or ensuring regulatory compliance for Clay-enriched lead data. Trigger with phrases … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/clay-pack/skills/clay-data-handling) |
| `compliance-audit` | core | Performs regulatory gap analysis across 7 compliance frameworks with a scored report card and prioritized remediation roadmap. Use when assessing a website or application for GDPR, CCPA, ADA, PCI-DSS, CAN-SPAM, COPPA, or SOC 2 compliance. … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/business-tools/general-legal-assistant/skills/compliance-audit) |
| `openrouter-compliance-review` | core | Review OpenRouter integration for regulatory compliance (SOC2, GDPR, HIPAA). Use when preparing for audits, evaluating data handling, or documenting compliance posture. Triggers: ''openrouter compliance'', ''openrouter gdpr'', ''openrouter … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/openrouter-pack/skills/openrouter-compliance-review) |
| `find-law-firm` | core | Use whenever the user wants to find, shortlist, vet, or enrich US B2B law firms — corporate, IP/patent, M&A and securities, employment, commercial litigation, regulatory/compliance, data privacy/cyber, real estate, and tax. Triggers on … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/mcp/servicegraph/skills/find-law-firm) |
| `supabase-data-handling` | core | Implement GDPR/CCPA compliance with Supabase: RLS for data isolation, user deletion via auth.admin.deleteUser(), data export via SQL, PII column management, backup/restore workflows, and retention policies. Use when handling sensitive … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/supabase-pack/skills/supabase-data-handling) |
| `twinmind-data-handling` | core | Handle TwinMind meeting data with GDPR compliance: transcript storage, memory vault management, data export, and deletion policies. Use when implementing data handling, or managing TwinMind meeting AI operations. Trigger with phrases like … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/twinmind-pack/skills/twinmind-data-handling) |
| `instantly-data-handling` | core | Implement Instantly.ai lead data management, GDPR/CAN-SPAM compliance, and list operations. Use when handling lead imports, managing block lists, implementing unsubscribe flows, or ensuring compliance with email regulations. Trigger with … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/instantly-pack/skills/instantly-data-handling) |
| `coderabbit-data-handling` | core | Implement CodeRabbit PII handling, data retention, and GDPR/CCPA compliance patterns. Use when handling sensitive data, implementing data redaction, configuring retention policies, or ensuring compliance with privacy regulations for … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/coderabbit-pack/skills/coderabbit-data-handling) |
| `flexport-data-handling` | core | Implement data handling for Flexport supply chain data including PII redaction, shipment data retention, GDPR compliance, and secure document management. Trigger: "flexport data handling", "flexport PII", "flexport GDPR", "flexport data … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/flexport-pack/skills/flexport-data-handling) |
| `mistral-data-handling` | core | Implement Mistral AI PII handling, data retention, and GDPR/CCPA compliance patterns. Use when handling sensitive data, implementing data redaction, configuring retention policies, or ensuring compliance with privacy regulations for … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/mistral-pack/skills/mistral-data-handling) |
| `apollo-data-handling` | core | Apollo.io data management and compliance. Use when handling contact data, implementing GDPR compliance, or managing data exports and retention. Trigger with phrases like "apollo data", "apollo gdpr", "apollo compliance", "apollo data … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/apollo-pack/skills/apollo-data-handling) |
| `posthog-data-handling` | core | PostHog PII handling, GDPR compliance, consent management, data deletion, property sanitization, and privacy-safe analytics configuration. Trigger: "posthog data", "posthog PII", "posthog GDPR", "posthog data retention", "posthog privacy", … | [source](https://github.com/jeremylongshore/claude-code-plugins-plus-skills/tree/e112938a/plugins/saas-packs/posthog-pack/skills/posthog-data-handling) |
## Source: kazukinagata/shinkoku
- Repository: [https://github.com/kazukinagata/shinkoku](https://github.com/kazukinagata/shinkoku) (commit `e610b30`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `tax-legal-context` | core | Background legal and regulatory context for the shinkoku tax filing plugin. Contains the standard disclaimer about the scope of tax information provided, the relationship to the Tax Accountant Act (税理士法), and tool limitations. This skill … | [source](https://github.com/kazukinagata/shinkoku/tree/e610b30/skills/tax-legal-context) |
| `tax-ebookkeeping-context` | core | Background context for the Electronic Bookkeeping Act (電子帳簿保存法) in the shinkoku tax filing plugin. Contains requirements for electronic bookkeeping, scanner storage, mandatory electronic transaction data storage, and shinkoku's compliance … | [source](https://github.com/kazukinagata/shinkoku/tree/e610b30/skills/tax-ebookkeeping-context) |
## Source: mohitagw15856/pm-claude-skills
- Repository: [https://github.com/mohitagw15856/pm-claude-skills](https://github.com/mohitagw15856/pm-claude-skills) (commit `876fa30`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `ai-usage-policy` | core | Write an AI usage policy people can actually follow — approved tools, data rules, disclosure duties, and review obligations, in one page instead of legal fog. Use when asked for a company AI policy, acceptable-use rules for … | [source](https://github.com/mohitagw15856/pm-claude-skills/tree/876fa30/plugins/pm-aiwork/skills/ai-usage-policy) |
| `compliance-checklist` | core | Generate a prioritised compliance checklist for GDPR, SOC 2, ISO 27001, FCA, HIPAA, or other frameworks with a gap analysis. Use when asked for a compliance checklist, gap analysis, readiness assessment, or audit preparation for any … | [source](https://github.com/mohitagw15856/pm-claude-skills/tree/876fa30/plugins/pm-legal/skills/compliance-checklist) |
| `sprint-velocity-analysis` | core | Analyze sprint velocity data and produce an engineering team health report covering delivery trends, capacity utilization, and improvement recommendations. Use when asked to analyze sprint velocity, review team delivery health, identify … | [source](https://github.com/mohitagw15856/pm-claude-skills/tree/876fa30/plugins/pm-engineering/skills/sprint-velocity-analysis) |
## Source: mukul975/Anthropic-Cybersecurity-Skills
- Repository: [https://github.com/mukul975/Anthropic-Cybersecurity-Skills](https://github.com/mukul975/Anthropic-Cybersecurity-Skills) (commit `673da1f`, retrieved 2026-07-14)
- License: Apache-2.0
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `hardening-windows-endpoint-with-cis-benchmark` | core | Hardens Windows endpoints using CIS (Center for Internet Security) Benchmark recommendations to reduce attack surface, enforce security baselines, and meet compliance requirements. Use when deploying new Windows workstations or servers, … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/hardening-windows-endpoint-with-cis-benchmark) |
| `achieving-cmmc-level-2-compliance` | core | Prepare a defense-contractor environment for CMMC Level 2 certification: scope CUI and FCI, implement the 110 NIST SP 800-171 Rev 2 security requirements across 14 families, compute the SPRS score with the DoD Assessment Methodology, … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/achieving-cmmc-level-2-compliance) |
| `hardening-linux-endpoint-with-cis-benchmark` | core | Hardens Linux endpoints using CIS Benchmark recommendations for Ubuntu, RHEL, and CentOS to reduce attack surface, enforce security baselines, and meet compliance requirements. Use when deploying new Linux servers, remediating audit … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/hardening-linux-endpoint-with-cis-benchmark) |
| `implementing-iso-27001-information-security-management` | core | ISO/IEC 27001:2022 is the international standard for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS). This skill covers the complete | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/implementing-iso-27001-information-security-management) |
| `analyzing-outlook-pst-for-email-forensics` | core | Analyze Microsoft Outlook PST and OST files for email forensic evidence including message content, headers, attachments, deleted items, and metadata using libpff, pst-utils, and forensic email analysis tools for legal investigations and … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/analyzing-outlook-pst-for-email-forensics) |
| `implementing-aws-security-hub` | core | This skill covers deploying AWS Security Hub as a centralized cloud security posture management platform that aggregates findings from GuardDuty, Inspector, Macie, and third-party tools. It details enabling security standards like CIS AWS … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/implementing-aws-security-hub) |
| `analyzing-macro-malware-in-office-documents` | core | Analyzes malicious VBA macros embedded in Microsoft Office documents (Word, Excel, PowerPoint) to identify download cradles, payload execution, persistence mechanisms, and anti-analysis techniques. Uses olevba, oledump, and VBA … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/analyzing-macro-malware-in-office-documents) |
| `performing-endpoint-forensics-investigation` | core | Performs digital forensics investigation on compromised endpoints including memory acquisition, disk imaging, artifact analysis, and timeline reconstruction. Use when investigating security incidents, collecting evidence for legal … | [source](https://github.com/mukul975/Anthropic-Cybersecurity-Skills/tree/673da1f/skills/performing-endpoint-forensics-investigation) |
## Source: nexscope-ai/eCommerce-Skills
- Repository: [https://github.com/nexscope-ai/eCommerce-Skills](https://github.com/nexscope-ai/eCommerce-Skills) (commit `56f3288`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `tiktok-shop-compliance` | core | TikTok Shop policies and compliance — restricted products, intellectual property, content guidelines | [source](https://github.com/nexscope-ai/eCommerce-Skills/tree/56f3288/tiktok-shop-compliance) |
| `ecommerce-social-media-marketing` | core | Social media marketing strategy for ecommerce brands. Content calendar planning, platform-specific strategies, social commerce optimization, influencer collaboration, and community building. Use when the user asks about social media … | [source](https://github.com/nexscope-ai/eCommerce-Skills/tree/56f3288/ecommerce-social-media-marketing) |
| `tiktok-shop-content-strategy` | core | TikTok Shop content creation strategy and planning. Trending formats, viral hooks, product showcasing, hashtag strategy, and content calendar development. Use when the user asks about TikTok content strategy, viral content creation, TikTok … | [source](https://github.com/nexscope-ai/eCommerce-Skills/tree/56f3288/tiktok-shop-content-strategy) |
## Source: open-gitagent/opengap
- Repository: [https://github.com/open-gitagent/opengap](https://github.com/open-gitagent/opengap) (commit `d7a8e2e`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `document-review` | core | Reviews financial documents (prospectuses, ADVs, marketing materials) for FINRA 2210 compliance, required disclosures, and balanced presentation. Use when reviewing financial statements, audit documents, regulatory filings, or when the … | [source](https://github.com/open-gitagent/opengap/tree/d7a8e2e/examples/full/skills/document-review) |
## Source: ruvnet/claude-code-flow
- Repository: [https://github.com/ruvnet/claude-code-flow](https://github.com/ruvnet/claude-code-flow) (commit `73914bd`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `AgentDB Memory Patterns` | core | Implement persistent memory patterns for AI agents using AgentDB. Includes session memory, long-term storage, pattern learning, and context management. Use when building stateful agents, chat systems, or intelligent assistants. | [source](https://github.com/ruvnet/claude-code-flow/tree/73914bd/.agents/skills/agentdb-memory-patterns) |
## Source: ruvnet/ruflo
- Repository: [https://github.com/ruvnet/ruflo](https://github.com/ruvnet/ruflo) (commit `73914bd`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `AgentDB Memory Patterns` | core | Implement persistent memory patterns for AI agents using AgentDB. Includes session memory, long-term storage, pattern learning, and context management. Use when building stateful agents, chat systems, or intelligent assistants. | [source](https://github.com/ruvnet/ruflo/tree/73914bd/.agents/skills/agentdb-memory-patterns) |
## Source: samber/cc-skills-golang
- Repository: [https://github.com/samber/cc-skills-golang](https://github.com/samber/cc-skills-golang) (commit `4881c01`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `golang-dependency-management` | core | Dependency management strategies for Golang projects — go.mod management, installing/upgrading packages, Minimal Version Selection, vulnerability scanning, outdated dependency tracking, binary size analysis, Dependabot/Renovate setup, … | [source](https://github.com/samber/cc-skills-golang/tree/4881c01/skills/golang-dependency-management) |
## Source: Sushegaad/Claude-Skills-Governance-Risk-and-Compliance
- Repository: [https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance](https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance) (commit `71d8920`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `gdpr-compliance` | core | Expert GDPR compliance assistant covering all four core workflows: (1) auditing code and systems for GDPR violations, (2) drafting GDPR-compliant documents such as privacy policies, Data Processing Agreements (DPAs), and consent notices, … | [source](https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance/tree/71d8920/plugins/gdpr-compliance/skills/gdpr-compliance) |
| `csrd` | core | Expert CSRD (Corporate Sustainability Reporting Directive, EU 2022/2464) compliance advisor. Use this skill whenever a user asks about CSRD, European Sustainability Reporting Standards (ESRS), double materiality assessment, sustainability … | [source](https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance/tree/71d8920/plugins/csrd/skills/csrd) |
| `eu-cra` | core | Expert EU Cyber Resilience Act (CRA) advisor for Regulation (EU) 2024/2847 — mandatory cybersecurity and vulnerability handling requirements for all products with digital elements (PDEs) sold in the EU. Use this skill for gap analysis, … | [source](https://github.com/Sushegaad/Claude-Skills-Governance-Risk-and-Compliance/tree/71d8920/plugins/eu-cra/skills/eu-cra) |
## Source: syahiidkamil/Software-Engineer-AI-Agent-Atlas
- Repository: [https://github.com/syahiidkamil/Software-Engineer-AI-Agent-Atlas](https://github.com/syahiidkamil/Software-Engineer-AI-Agent-Atlas) (commit `fc0bf11`, retrieved 2026-07-14)
- License: no explicit license — referenced by link only
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `super-product-owner` | core | Complete Product Owner / Product Manager capability — a wiki-style knowledge map of product practice in active software development: the role and its boundaries, strategy cascade (vision → OKRs → roadmap → backlog), continuous discovery, … | [source](https://github.com/syahiidkamil/Software-Engineer-AI-Agent-Atlas/tree/fc0bf11/.claude/skills/super-product-owner) |
## Source: vibeeval/vibecosystem
- Repository: [https://github.com/vibeeval/vibecosystem](https://github.com/vibeeval/vibecosystem) (commit `cea9462`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `compliance-patterns` | core | GDPR data handling, audit logging, data classification, retention policies, and consent management for regulatory compliance. | [source](https://github.com/vibeeval/vibecosystem/tree/cea9462/skills/compliance-patterns) |
| `gdpr-compliance` | core | GDPR compliance - data subject rights, lawful basis, DPIA, privacy by design, breach notification, consent management, cross-border transfers, PII masking | [source](https://github.com/vibeeval/vibecosystem/tree/cea9462/skills/gdpr-compliance) |
| `kvkk-compliance` | core | KVKK and GDPR compliance patterns - consent management, right to erasure, breach notification, audit logging, cookie consent, and data classification. | [source](https://github.com/vibeeval/vibecosystem/tree/cea9462/skills/kvkk-compliance) |
| `hipaa-compliance` | core | HIPAA compliance - PHI protection, technical/administrative/physical safeguards, minimum necessary standard, BAA requirements, de-identification, access logging | [source](https://github.com/vibeeval/vibecosystem/tree/cea9462/skills/hipaa-compliance) |
| `content-strategy` | core | Content marketing strategy - content audit, editorial calendar, SEO optimization, content funnel (TOFU/MOFU/BOFU), performance metrics, developer content, social media planning | [source](https://github.com/vibeeval/vibecosystem/tree/cea9462/skills/content-strategy) |
## Source: zebbern/claude-code-guide
- Repository: [https://github.com/zebbern/claude-code-guide](https://github.com/zebbern/claude-code-guide) (commit `d2c5280`, retrieved 2026-07-14)
- License: MIT
| Skill | Tier | What it adds | Upstream |
|---|---|---|---|
| `regulatory-audit-generator` | core | Builds compliance checklists for business scenarios involving GDPR, PIPL, or advertising/data laws. Outputs a structured checklist with check items, legal basis, risk levels, and actionable recommendations. Triggered by requests like \"run … | [source](https://github.com/zebbern/claude-code-guide/tree/d2c5280/skills/regulatory-audit-generator) |

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# Berufsbild (Deutschland) — Regulatory-Affairs-Manager/in
> **Quelle:** BERUFENET, Bundesagentur für Arbeit — Beruf-ID 15006,
> KldB 2010: B 81884 · via öffentliche BERUFENET-API,
> abgerufen 2026-07-12. Automatisches Label-Matching
> (Score 1.00); Inhalte paraphrasiert/gekürzt, Volltext beim
> Original: https://web.arbeitsagentur.de/berufenet/beruf/15006
## Aufgaben und Tätigkeiten kompakt
Regulatory-Affairs-Manager und -Managerinnen wirken bei der Beantragung klinischer Prüflizenzen mit. Sie überprüfen dazu Dokumente, die für Zulassungen relevant sind und halten Produktdokumentationen fest. Zudem betreuen sie die Produkte bis zur Marktreife und klären Mitarbeiter und Mitarbeiterinnen der klinischen Forschung über amtliche Vorgaben auf. Außerdem kontrollieren sie die Inhalte von Beipackzetteln, Texten auf der Verpackung und weiteren Fachinformationen. Als Drug-Safety-Manager und -Managerinnen oder Stufenplanbeauftragte konzentrieren sie sich darauf die Arzneimittelsicherheit zu überwachen. Sie sammeln Meldungen zu Arzneimittelrisiken, bewerten Berichte über mögliche Nebenwirkungen und leiten sie an die entsprechenden Stellen weiter.
## Tätigkeitsbezeichnungen
Regulatory-Affairs-Manager/in
Berufsbezeichnung in englischer SpracheRegulatory affairs officer (m/f)
## Die Tätigkeit im Überblick
Regulatory-Affairs-Manager und -Mangerinnen arbeiten eng mit behördlichen Institutionen und Prüfstellen zusammen, die über die Marktzulassung von Arzneien entscheiden.
## Trends
KI und Big Data in der ArzneimittelentwicklungMit "Big Data" bezeichnet man große Mengen strukturierter oder unstrukturierter Daten, deren Umfang zudem schnell wächst beziehungsweise die sehr rasch ausgetauscht werden. Die Daten können in unterschiedlichsten Formaten, etwa als Text-, Bild- oder Videodateien vorliegen. Es können zum Beispiel Produktions- und Transportdaten von Unternehmen sein, Daten aus Finanztransaktionen oder zum Online-Suchverhalten. Mit manuellen und herkömmlichen Methoden der Datenverarbeitung kann diese Datenflut nicht mehr ausgewertet werden. Es bedarf einer speziellen Big-Data-Analyse, basierend auf Algorithmen und intelligenten Mustererkennungstechnologien. s. auch "Data Mining".
" name="Big Data">Big Data und englisch: Artificial Intelligence (AI)
Teilgebiet der Informatik, das Strukturen menschlicher Intelligenz untersucht, auf Computer überträgt und Programme für intelligente Problemlösungen entwickelt, z. B. Spracherkennung
" name="Künstliche Intelligenz (KI)">Künstliche Intelligenz (KI) helfen Forschenden bei der schnelleren Entwicklung von Therapien und neuer Medikamente. Mit minimaler Laborarbeit lassen sich die effektivsten Wirkstoffkombinationen aufspüren oder Erkrankungen aus Gesundheitsdaten ablesen. Sie sollen zudem genauere Vorhersagen über die Auswirkungen unterschiedlicher Therapien auf den Krankheitsverlauf ermöglichen. Experten und Expertinnen hoffen auf eine schnellere und kostengünstigere Arzneientwicklung und einen großen Schritt hin zur personalisierten Medizin. Dadurch sollen Patienten und Patientinnen schneller und zuverlässiger auf persönlich zugeschnittene Medikamente zurückgreifen können. Fachleute werden sich zukünftig mit diesem herausfordernden und umfangreichen Tätigkeitsfeld beschäftigen.
Maßgeschneiderte Medikamente aus dem 3-D-DruckerIn den USA wurde sie bereits freigegeben - die erste Tablette, die mittels 3-D-Druck hergestellt wurde. Auch in Deutschland suchen Forschende nach Verfahren und Materialien für die pharmazeutische Industrie. Der größte Vorteil liegt dabei in der Personalisierung der Medikamente. Dosierung und Wirkstoffkombinationen werden an die Patienten und Patientinnen angepasst. Es entsteht die sogenannte Polypille. Fachkräfte der Pharmaproduktion und Zuständige für Zulassungsfragen stehen durch dieses Produktionsverfahren vor neuen Herausforderungen.
## Aufgaben und Tätigkeiten im Einzelnen
Marktzulassung von Arzneien organisieren
neue Produkte als Arzneimittel nach gesetzlichen Vorgaben registrieren
Genehmigung der Forschungsprojekte beantragen, Lizenzen für medizinische Prüfreihen erwirken
Zulassungsanträge für nationale und internationale Verfahren erstellen, Zulassungsdokumentationen erstellen und pflegen
Zulassungsverfahren betreuen, Änderungs- und Verlängerungsanträge planen und erstellen
Beipackzettel, Faltschachteltexte und andere Fachinformationen zum Produkt inhaltlich kontrollieren
nationale und internationale Vorschriften, Verfahrensrichtlinien und Grundsätze berücksichtigen
Kontakte zu nationalen und internationalen Zulassungsbehörden aufbauen und pflegen
Kollegen/Kolleginnen in der klinischen Forschung zu behördlichen Auflagen beraten
Fristen einhalten
Überwachungssysteme für Arzneimittel einrichten und pflegen
Meldungen über Arzneimittelrisiken sammeln
Berichte über vermutete Nebenwirkungen bewerten und an interne Stellen im Pharmabetrieb sowie zuständige Behörden weiterleiten
## Arbeitsbereiche/Branchen
Regulatory-Affairs-Manager und -Managerinnen finden Beschäftigung
in der chemischen und pharmazeutischen Industrie
Sie arbeiten auch
bei Zulassungsstellen für Arzneimittel
in Gesundheitsbehörden und öffentlichen Einrichtungen
bei pharmazeutischen Forschungs- und Entwicklungsinstituten
bei Fachgesellschaften und Verbänden der Pharmaindustrie

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# Market evidence report — regulatory-affairs-manager
Source: **53 real job ads** (JSearch API, countries: us 36, gb 17), extracted into the MSSQL evidence store; as of 2026-07-19.
This report contains extracted, aggregated facts only — no ad text is
reproduced (copyright / platform terms).
## Seniority distribution
| Seniority | Ads | Share |
|---|---|---|
| mid | 33 | 62 % |
| senior | 14 | 26 % |
| lead | 6 | 11 % |
## Tools — full market ranking
| # | Item | Ads | Share |
|---|---|---|---|
| 1 | Microsoft Office | 9 | 17 % |
| 2 | Adobe Acrobat | 3 | 6 % |
| 3 | Smartsheet | 3 | 6 % |
## Hard skills — full market ranking
| # | Item | Ads | Share |
|---|---|---|---|
| 1 | regulatory submissions | 16 | 30 % |
| 2 | risk assessment | 15 | 28 % |
| 3 | project management | 14 | 26 % |
| 4 | regulatory strategy | 14 | 26 % |
| 5 | data analysis | 12 | 23 % |
| 6 | regulatory compliance | 12 | 23 % |
| 7 | regulatory affairs | 10 | 19 % |
| 8 | regulatory strategy development | 10 | 19 % |
| 9 | stakeholder management | 7 | 13 % |
| 10 | regulatory analysis | 5 | 9 % |
| 11 | negotiation | 4 | 8 % |
| 12 | problem solving | 4 | 8 % |
| 13 | product registration | 4 | 8 % |
| 14 | regulatory intelligence | 4 | 8 % |
| 15 | advertising review | 3 | 6 % |
| 16 | compliance management | 3 | 6 % |
| 17 | dossier development | 3 | 6 % |
| 18 | global regulatory science | 3 | 6 % |
| 19 | government relations | 3 | 6 % |
| 20 | labeling negotiation | 3 | 6 % |
| 21 | legislative affairs | 3 | 6 % |
| 22 | policy analysis | 3 | 6 % |
| 23 | policy development | 3 | 6 % |
| 24 | risk mitigation | 3 | 6 % |
| 25 | strategic planning | 3 | 6 % |
| 26 | workflow management | 3 | 6 % |
## Methods — full market ranking
| # | Item | Ads | Share |
|---|---|---|---|
| 1 | continuous improvement | 5 | 9 % |
| 2 | coalition building | 3 | 6 % |
| 3 | fda regulations | 3 | 6 % |
## Responsibilities — full market ranking
| # | Item | Ads | Share |
|---|---|---|---|
| 1 | regulatory monitoring | 6 | 11 % |
| 2 | regulatory guidance | 5 | 9 % |
| 3 | regulatory compliance | 4 | 8 % |
| 4 | regulatory submissions | 4 | 8 % |
| 5 | strategy development | 4 | 8 % |
| 6 | team leadership | 4 | 8 % |
| 7 | cross-functional collaboration | 3 | 6 % |
| 8 | relationship management | 3 | 6 % |
| 9 | staff development | 3 | 6 % |
| 10 | strategy implementation | 3 | 6 % |
| 11 | submission preparation | 3 | 6 % |
## Regional breakdown
> **Corpus note:** 53 relevant ads in total — below the 100-ad target for a fully reliable ranking. Percentages above should be read as indicative.
### US (us)
36 ads.
**Top hard skills:**
- regulatory submissions — 36 % (13 ads)
- regulatory strategy — 31 % (11 ads)
- risk assessment — 25 % (9 ads)
- data analysis — 22 % (8 ads)
- project management — 22 % (8 ads)
- regulatory compliance — 19 % (7 ads)
- stakeholder management — 19 % (7 ads)
- regulatory affairs — 17 % (6 ads)
- regulatory strategy development — 14 % (5 ads)
- dossier development — 8 % (3 ads)
**Top tools:**
- Microsoft Office — 22 % (8 ads)
- Adobe Acrobat — 8 % (3 ads)
- Smartsheet — 8 % (3 ads)
- SharePoint — 6 % (2 ads)
- Veeva Vault — 6 % (2 ads)
**Seniority:** mid 67 % · senior 25 % · lead 8 %
### UK (gb)
**Insufficient evidence** — 17 ads (minimum for a regional ranking: 30). No ranking is reported for this region.
### EU/DACH (de, at, ch, nl)
**Insufficient evidence** — 0 ads (minimum for a regional ranking: 30). No ranking is reported for this region.
## Job title variants in the market
| Title | Ads |
|---|---|
| Regulatory Affairs Manager | 7 |
| Director, Regulatory Affairs | 2 |
| Manager, Regulatory Affairs - Tactical Implementation | 2 |
| Quality - Regulatory Affairs Manager | 2 |
| Senior Manager, Regulatory Affairs | 2 |
| Associate Director Regulatory Affairs, Oncology | 1 |
| Associate Director, Regulatory Affairs (on-site) | 1 |
| Associate Director, Regulatory Affairs Project Planning & Coordination | 1 |
| Associate Manager - International Legislative and Regulatory Affairs | 1 |
| Associate Manager, International Legislative and Regulatory Affairs | 1 |
| Director - Regulatory Affairs Resource, Analytics and Insights Lead | 1 |
| Director Global Regulatory Affairs | 1 |
| Director Regulatory Affairs | 1 |
| Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) | 1 |
| Director, Policy & Regulatory Affairs | 1 |
| Director, Regulatory Affairs - Neurology MedTech | 1 |
| Global Regulatory Affairs Manager - Medical Devices | 1 |
| Global Regulatory Affairs Manager (Contract) | 1 |
| Head of Regulatory Affairs | 1 |
| Manager, Quality Assurance & Regulatory Affairs | 1 |
| Manager, Regulatory Affairs - Advertising and Promotion | 1 |
| Manager, Regulatory Affairs - Cosmetics (Global) | 1 |
| Manager/Senior Manager, Global Regulatory Affairs | 1 |
| Mgr Global Regulatory Scientist, Reg Aff | 1 |
| Policy & Regulatory Affairs Manager | 1 |
Methodology: entities extracted per ad ({hard_skills, tools, methods, responsibilities, seniority}), normalized, counted as DISTINCT ads per entity; report threshold ≥ 3 ads. Headline sections in skills.md/tools.md use the stricter ≥ 20 % threshold.

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# Occupation profile — regulatory affairs manager
- **ESCO URI:** http://data.europa.eu/esco/occupation/779d13be-60b4-48f3-a339-fe483be96c7f
- **ESCO code:** 2619.12
- **ISCO-08 group:** 2619 — Legal professionals not elsewhere classified
- **O*NET-SOC:** 11-9199.01 — Regulatory Affairs Managers (match: exactMatch)
## Description (ESCO)
Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.
## Definition
nan
## Alternative labels
- compliance manager
- regulatory manager
- bank compliance officer
- regulatory compliance officer
- regulatory affairs specialist
- regulatory affairs officer
- chief compliance officer
- regulatory compliance manager
- regulatory affairs portfolio leader

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# Competences — regulatory affairs manager
Source: ESCO v1.2.1 occupation-skill relations (http://data.europa.eu/esco/occupation/779d13be-60b4-48f3-a339-fe483be96c7f).
## Essential
- **advise on efficiency improvements** (skill/competence)
- **analyse legislation** (skill/competence)
- **business analysis** (knowledge)
- **company policies** (knowledge)
- **comply with legal regulations** (skill/competence)
- **corporate sustainability** (knowledge)
- **develop company strategies** (skill/competence)
- **develop licensing agreements** (skill/competence)
- **develop organisational policies** (skill/competence)
- **enforce financial policies** (skill/competence)
- **ensure compliance with company regulations** (skill/competence)
- **ensure compliance with legal requirements** (skill/competence)
- **ensure compliance with policies** (skill/competence)
- **ensure products meet regulatory requirements** (skill/competence)
- **identify legal requirements** (skill/competence)
- **implement strategic planning** (skill/competence)
- **integrate strategic foundation in daily performance** (skill/competence)
- **interpret technical requirements** (skill/competence)
- **manage relationships with stakeholders** (skill/competence)
- **meet the requirements of legal bodies** (skill/competence)
- **monitor company policy** (skill/competence)
- **monitor compliance with licensing agreements** (skill/competence)
- **organisational policies** (knowledge)
- **organise business documents** (skill/competence)
- **prepare licence agreements** (skill/competence)
- **strategic planning** (knowledge)
## Optional
- advise on legal decisions (skill/competence)
- analyse legal enforceability (skill/competence)
- analyse scientific data (skill/competence)
- banking activities (knowledge)
- communicate with banking professionals (skill/competence)
- contact scientists (skill/competence)
- copyright legislation (knowledge)
- corporate law (knowledge)
- corporate social responsibility (knowledge)
- financial jurisdiction (knowledge)
- financial products (knowledge)
- hazard analysis and critical control points (knowledge)
- identify hazards in the workplace (skill/competence)
- intellectual property law (knowledge)
- international trade (knowledge)
- keep updated on innovations in various business fields (skill/competence)
- law enforcement (knowledge)
- nuclear legislation (knowledge)
- patents (knowledge)
- procurement legislation (knowledge)
- protect personal data and privacy (skill/competence)
- provide legal advice (skill/competence)
- quality standards (knowledge)
- support managers (skill/competence)
- tax legislation (knowledge)
<!-- market-evidence -->
## Market evidence (job-ad analysis, 53 ads, as of 2026-07-19)
Share of analyzed job ads mentioning the item (threshold ≥ 20 %). Source: JSearch/Adzuna APIs.
### Hard skills
- regulatory submissions — **30 %**
- risk assessment — **28 %**
- regulatory strategy — **26 %**
- project management — **26 %**
- data analysis — **23 %**
- regulatory compliance — **23 %**
- regulatory affairs — **19 %**
- regulatory strategy development — **19 %**
<!-- market-evidence -->

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# Tasks & work activities — regulatory affairs manager
Source: O*NET 30.3, occupation 11-9199.01 (Regulatory Affairs Managers).
## Task statements
- **[Core]** Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- **[Core]** Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- **[Core]** Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- **[Core]** Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- **[Core]** Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- **[Core]** Establish regulatory priorities or budgets and allocate resources and workloads.
- **[Core]** Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- **[Core]** Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- **[Core]** Maintain current knowledge of relevant regulations, including proposed and final rules.
- **[Core]** Manage activities such as audits, regulatory agency inspections, or product recalls.
- **[Core]** Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- **[Core]** Participate in the development or implementation of clinical trial protocols.
- **[Core]** Provide responses to regulatory agencies regarding product information or issues.
- **[Core]** Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- **[Core]** Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- **[Core]** Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- **[Core]** Train staff in regulatory policies or procedures.
- **[Core]** Contribute to the development or implementation of business unit strategic and operating plans.
- **[Core]** Coordinate internal discoveries and depositions with legal department staff.
- **[Core]** Develop and maintain standard operating procedures or local working practices.
- **[Core]** Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- **[Core]** Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- **[Core]** Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- **[Core]** Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- **[Core]** Monitor regulatory affairs trends related to environmental issues.
- **[Core]** Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- **[Supplemental]** Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
## Detailed work activities
- Advise others on legal or regulatory compliance matters.
- Communicate organizational policies and procedures.
- Conduct employee training programs.
- Confer with organizational members to accomplish work activities.
- Coordinate operational activities with external stakeholders.
- Coordinate regulatory documentation activities.
- Coordinate with external parties to exchange information.
- Develop operating strategies, plans, or procedures.
- Develop organizational goals or objectives.
- Develop organizational methods or procedures.
- Develop organizational policies or programs.
- Establish interpersonal business relationships to facilitate work activities.
- Evaluate environmental impact of operational or development activities.
- Evaluate potential of products, technologies, or resources.
- Examine marketing materials to ensure compliance with policies or regulations.
- Implement organizational process or policy changes.
- Maintain knowledge of current developments in area of expertise.
- Maintain regulatory or compliance documentation.
- Manage control system activities in organizations.
- Manage documentation to ensure organization or accuracy.
- Monitor external affairs or events affecting business operations.
- Monitor organizational compliance with regulations.
- Monitor organizational procedures to ensure proper functioning.
- Prepare operational budgets.
- Prepare reports related to compliance matters.
- Prepare staff schedules or work assignments.
- Represent the organization in external relations.
- Review documents or materials for compliance with policies or regulations.

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# Tools & technology — regulatory affairs manager
Source: O*NET 30.3 'Software Skills' for 11-9199.01.
| Software | Category | Hot technology |
|---|---|---|
| Tableau | Business intelligence and data analysis software | yes |
| Microsoft Access | Data base user interface and query software | yes |
| Structured query language SQL | Data base user interface and query software | yes |
| Adobe Acrobat | Document management software | yes |
| Microsoft SharePoint | Document management software | yes |
| Microsoft Outlook | Electronic mail software | yes |
| SAP software | Enterprise resource planning ERP software | yes |
| Microsoft Office software | Office suite software | yes |
| Microsoft Windows | Operating system software | yes |
| Microsoft PowerPoint | Presentation software | yes |
| Microsoft Visio | Process mapping and design software | yes |
| Microsoft Project | Project management software | yes |
| Microsoft Excel | Spreadsheet software | yes |
| Microsoft Word | Word processing software | yes |
| Analyse-it | Analytical or scientific software | |
| Statistical analysis software | Analytical or scientific software | |
| Aris Global Register | Compliance software | |
| MediRegs E-dition Compliance Monitor | Compliance software | |
| MediRegs Pharmaceutical Regulation Suite | Compliance software | |
| MediRegs Regulation and Reimbursement Suite | Compliance software | |
| MediRegs Risk Assessment Manager | Compliance software | |
| Pilgrim Regulatory Submission | Compliance software | |
| Samarind RMS | Compliance software | |
| SAP EHS Management | Compliance software | |
| Thomson Reuters Liquent InSight Suite | Compliance software | |
| Database software | Data base user interface and query software | |
| Document publishing software | Desktop publishing software | |
| Integrated development environment IDE software | Development environment software | |
| Software development tools | Development environment software | |
| Adlib Express | Document management software | |
| Axway eSubmissions | Document management software | |
| Datafarm a-Pulse | Document management software | |
| Datafarm eCTDGatekeeper | Document management software | |
| Datafarm eCTDViewer | Document management software | |
| Datafarm S-Cubed | Document management software | |
| DoubleBridge ROSETTA Phoenix eCTD Viewer | Document management software | |
| DoubleBridge ROSETTA Pyramid | Document management software | |
| DoubleBridge ROSETTA Sceptre | Document management software | |
| DoubleBridge ROSETTA Scribe | Document management software | |
| Electronic common technical document eCTD software | Document management software | |
| Electronic common technical document eCTD validating software | Document management software | |
| Electronic common technical document eCTD viewing software | Document management software | |
| Electronic document management system EDMS | Document management software | |
| Enterprise content management ECM software | Document management software | |
| Extedo DOCvalidator | Document management software | |
| Extedo eCTDmanager Suite | Document management software | |
| Extedo PLmanager | Document management software | |
| GlobalSubmit REVIEW | Document management software | |
| GlobalSubmit VALIDATE | Document management software | |
| Image Solutions eCTDXpress | Document management software | |
| Image Solutions ISIPublisher | Document management software | |
| Lorenz DocuBridge | Document management software | |
| Lorenz eValidator | Document management software | |
| Lorenz labelBridge | Document management software | |
| MedXView eCTDauditor | Document management software | |
| Octagon StartingPoint | Document management software | |
| Octagon ViewPoint eCTD Complete | Document management software | |
| Take Solutions PharmaReady Document Management System | Document management software | |
| Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD | Document management software | |
| Virtify eCTD | Document management software | |
| IBM Notes | Electronic mail software | |
| XML authoring software | Enterprise application integration software | |
| Dialog DialogLink | Information retrieval or search software | |
| Web browser software | Internet browser software | |
| Total quality management TQM software | Project management software | |
| MasterControl software | Risk management data and analysis software | |
| Risk management software | Risk management data and analysis software | |