# Regulatory Affairs Specialists > Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. - Code: 13-1041.07 (O*NET-SOC; SOC 2018 13-1041) - Family: [Business & Financial](https://foundation.org.ai/occupations#family-13), one of its 50 occupations - Tasks: 30 tasks (24 core and 6 supplemental) - Page: https://foundation.org.ai/occupations/13-1041.07 - JSON: https://foundation.org.ai/data/tasks/13-1041.07.json ## What the work is made of 1. Coordinate efforts associated with the preparation of regulatory documents or submissions. Core task · Task 18054 · Rated by 20 occupational experts, August 2019 2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Core task · Task 18045 · Rated by 20 occupational experts, August 2019 3. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. Core task · Task 18061 · Rated by 20 occupational experts, August 2019 4. Coordinate, prepare, or review regulatory submissions for domestic or international projects. Core task · Task 18048 · Rated by 20 occupational experts, August 2019 5. Prepare or maintain technical files as necessary to obtain and sustain product approval. Core task · Task 18062 · Rated by 20 occupational experts, August 2019 6. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Core task · Task 18049 · Rated by 20 occupational experts, August 2019 7. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. Core task · Task 18055 · Rated by 20 occupational experts, August 2019 8. Coordinate recall or market withdrawal activities as necessary. Core task · Task 18067 · Rated by 20 occupational experts, August 2019 9. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Core task · Task 18052 · Rated by 20 occupational experts, August 2019 10. Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. Core task · Task 18070 · Rated by 20 occupational experts, August 2019 11. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. Core task · Task 18051 · Rated by 20 occupational experts, August 2019 12. Identify relevant guidance documents, international standards, or consensus standards. Core task · Task 21094 · Rated by 20 occupational experts, August 2019 13. Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Core task · Task 18050 · Rated by 20 occupational experts, August 2019 14. Review clinical protocols to ensure collection of data needed for regulatory submissions. Core task · Task 18065 · Rated by 20 occupational experts, August 2019 15. Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. Core task · Task 21095 · Rated by 20 occupational experts, August 2019 16. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Core task · Task 18058 · Rated by 20 occupational experts, August 2019 17. Recommend changes to company procedures in response to changes in regulations or standards. Core task · Task 18063 · Rated by 20 occupational experts, August 2019 18. Participate in internal or external audits. Core task · Task 18060 · Rated by 20 occupational experts, August 2019 19. Compile and maintain regulatory documentation databases or systems. Core task · Task 18053 · Rated by 20 occupational experts, August 2019 20. Write or update standard operating procedures, work instructions, or policies. Core task · Task 18066 · Rated by 20 occupational experts, August 2019 21. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. Core task · Task 18059 · Rated by 20 occupational experts, August 2019 22. Develop or track quality metrics. Core task · Task 18068 · Rated by 20 occupational experts, August 2019 23. Develop or conduct employee regulatory training. Core task · Task 18056 · Rated by 20 occupational experts, August 2019 24. Recommend adjudication of product complaints. Core task · Task 21096 · Rated by 20 occupational experts, August 2019 25. Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. Supplemental task · Task 19553 · Rated by 20 occupational experts, August 2019 26. Direct the collection and preparation of laboratory samples as requested by regulatory agencies. Supplemental task · Task 18069 · Rated by 20 occupational experts, August 2019 27. Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. Supplemental task · Task 18064 · Rated by 20 occupational experts, August 2019 28. Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops. Supplemental task · Task 19557 · Rated by 20 occupational experts, August 2019 29. Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. Supplemental task · Task 19552 · Rated by 20 occupational experts, August 2019 30. Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. 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