# Regulatory Affairs Managers > Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. - Code: 11-9199.01 (O*NET-SOC; SOC 2018 11-9199) - Family: [Management](https://foundation.org.ai/occupations#family-11), one of its 59 occupations - Tasks: 27 tasks (26 core and 1 supplemental) - Page: https://foundation.org.ai/occupations/11-9199.01 - JSON: https://foundation.org.ai/data/tasks/11-9199.01.json ## What the work is made of 1. Develop regulatory strategies and implementation plans for the preparation and submission of new products. Core task · Task 18026 · Rated by 23 occupational experts, August 2024 2. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Core task · Task 18037 · Rated by 23 occupational experts, August 2024 3. Direct the preparation and submission of regulatory agency applications, reports, or correspondence. Core task · Task 18022 · Rated by 23 occupational experts, August 2024 4. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. Core task · Task 18029 · Rated by 23 occupational experts, August 2024 5. Provide responses to regulatory agencies regarding product information or issues. Core task · Task 18035 · Rated by 23 occupational experts, August 2024 6. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Core task · Task 18036 · Rated by 23 occupational experts, August 2024 7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Core task · Task 18024 · Rated by 23 occupational experts, August 2024 8. Manage activities such as audits, regulatory agency inspections, or product recalls. Core task · Task 18031 · Rated by 23 occupational experts, August 2024 9. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Core task · Task 18025 · Rated by 23 occupational experts, August 2024 10. Maintain current knowledge of relevant regulations, including proposed and final rules. Core task · Task 18030 · Rated by 23 occupational experts, August 2024 11. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Core task · Task 18023 · Rated by 23 occupational experts, August 2024 12. Direct documentation efforts to ensure compliance with domestic and international regulations and standards. Core task · Task 21087 · Rated by 23 occupational experts, August 2024 13. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. Core task · Task 18038 · Rated by 23 occupational experts, August 2024 14. Participate in the development or implementation of clinical trial protocols. Core task · Task 18034 · Rated by 23 occupational experts, August 2024 15. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. Core task · Task 18028 · Rated by 23 occupational experts, August 2024 16. Establish procedures or systems for publishing document submissions in hardcopy or electronic formats. Core task · Task 18043 · Rated by 23 occupational experts, August 2024 17. Establish regulatory priorities or budgets and allocate resources and workloads. Core task · Task 18027 · Rated by 23 occupational experts, August 2024 18. Train staff in regulatory policies or procedures. Core task · Task 18039 · Rated by 23 occupational experts, August 2024 19. Develop and maintain standard operating procedures or local working practices. Core task · Task 18042 · Rated by 23 occupational experts, August 2024 20. Contribute to the development or implementation of business unit strategic and operating plans. Core task · Task 18040 · Rated by 23 occupational experts, August 2024 21. Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives. Core task · Task 19531 · Rated by 23 occupational experts, August 2024 22. Coordinate internal discoveries and depositions with legal department staff. Core task · Task 18041 · Rated by 23 occupational experts, August 2024 23. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. Core task · Task 18032 · Rated by 23 occupational experts, August 2024 24. Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations. Core task · Task 19529 · Rated by 23 occupational experts, August 2024 25. Monitor regulatory affairs trends related to environmental issues. Core task · Task 19532 · Rated by 23 occupational experts, August 2024 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 task · Task 19530 · Rated by 23 occupational experts, August 2024 27. Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions. Supplemental task · Task 18044 · Rated by 23 occupational experts, August 2024 ## More in Management - [Administrative Services Managers](https://foundation.org.ai/occupations/11-3012.00): 18 tasks - [Advertising and Promotions Managers](https://foundation.org.ai/occupations/11-2011.00): 30 tasks - [Architectural and Engineering Managers](https://foundation.org.ai/occupations/11-9041.00): 19 tasks - [Biofuels Production Managers](https://foundation.org.ai/occupations/11-3051.03): 14 tasks - [Biofuels/Biodiesel Technology and Product Development Managers](https://foundation.org.ai/occupations/11-9041.01): 18 tasks - [Biomass Power Plant Managers](https://foundation.org.ai/occupations/11-3051.04): 19 tasks - [Brownfield Redevelopment Specialists and Site Managers](https://foundation.org.ai/occupations/11-9199.11): 23 tasks - [Chief Executives](https://foundation.org.ai/occupations/11-1011.00): 31 tasks - [Chief Sustainability Officers](https://foundation.org.ai/occupations/11-1011.03): 18 tasks - 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