# 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.
