regulatory-affairs-manager/references/tasks.md

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.