Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- Tasks
- 27 tasks26 core, 1 supplemental
- Family
- ManagementOne of its 59 occupations
- Code
- 11-9199.01SOC 2018: 11-9199
What the work is made of
26 core tasks and 1 supplemental, each quoted as published, with the survey it came from.
Core: central to the jobSupplemental: done by some, not all
- Task 1. Develop regulatory strategies and implementation plans for the preparation and submission of new products.Core taskTask 18026Rated by 23 occupational experts, August 2024
- Task 2. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Core taskTask 18037Rated by 23 occupational experts, August 2024
- Task 3. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.Core taskTask 18022Rated by 23 occupational experts, August 2024
- Task 4. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.Core taskTask 18029Rated by 23 occupational experts, August 2024
- Task 5. Provide responses to regulatory agencies regarding product information or issues.Core taskTask 18035Rated by 23 occupational experts, August 2024
- Task 6. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.Core taskTask 18036Rated by 23 occupational experts, August 2024
- Task 7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.Core taskTask 18024Rated by 23 occupational experts, August 2024
- Task 8. Manage activities such as audits, regulatory agency inspections, or product recalls.Core taskTask 18031Rated by 23 occupational experts, August 2024
- Task 9. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.Core taskTask 18025Rated by 23 occupational experts, August 2024
- Task 10. Maintain current knowledge of relevant regulations, including proposed and final rules.Core taskTask 18030Rated by 23 occupational experts, August 2024
- Task 11. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.Core taskTask 18023Rated by 23 occupational experts, August 2024
- Task 12. Direct documentation efforts to ensure compliance with domestic and international regulations and standards.Core taskTask 21087Rated by 23 occupational experts, August 2024
- Task 13. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Core taskTask 18038Rated by 23 occupational experts, August 2024
- Task 14. Participate in the development or implementation of clinical trial protocols.Core taskTask 18034Rated by 23 occupational experts, August 2024
- Task 15. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.Core taskTask 18028Rated by 23 occupational experts, August 2024
- Task 16. Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.Core taskTask 18043Rated by 23 occupational experts, August 2024
- Task 17. Establish regulatory priorities or budgets and allocate resources and workloads.Core taskTask 18027Rated by 23 occupational experts, August 2024
- Task 18. Train staff in regulatory policies or procedures.Core taskTask 18039Rated by 23 occupational experts, August 2024
- Task 19. Develop and maintain standard operating procedures or local working practices.Core taskTask 18042Rated by 23 occupational experts, August 2024
- Task 20. Contribute to the development or implementation of business unit strategic and operating plans.Core taskTask 18040Rated by 23 occupational experts, August 2024
- Task 21. Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.Core taskTask 19531Rated by 23 occupational experts, August 2024
- Task 22. Coordinate internal discoveries and depositions with legal department staff.Core taskTask 18041Rated by 23 occupational experts, August 2024
- Task 23. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.Core taskTask 18032Rated by 23 occupational experts, August 2024
- Task 24. Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.Core taskTask 19529Rated by 23 occupational experts, August 2024
- Task 25. Monitor regulatory affairs trends related to environmental issues.Core taskTask 19532Rated by 23 occupational experts, August 2024
- Task 26. 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 taskTask 19530Rated by 23 occupational experts, August 2024
- Task 27. Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.Supplemental taskTask 18044Rated by 23 occupational experts, August 2024
Where this comes from
Quoted from the U.S. Department of Labor, and credited. Nothing on this page is written by us.
How we copy and credit sources- Published byO*NET 29.0, U.S. Department of LaborEmployment and Training Administration
- ClassificationStandard Occupational Classification 2018, 11-9199
- LicenseCC BY 4.0Free to copy and reuse, with credit
- Changed by usNothing.
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