Org.AI Foundation Partner

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.

Tasks
30 tasks24 core, 6 supplemental
Family
Business & FinancialOne of its 50 occupations
Code
13-1041.07SOC 2018: 13-1041

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What the work is made of

24 core tasks and 6 supplemental, each quoted as published, with the survey it came from.

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Core: central to the jobSupplemental: done by some, not all

  1. Task 1. Coordinate efforts associated with the preparation of regulatory documents or submissions.Core taskTask 18054Rated by 20 occupational experts, August 2019
  2. Task 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 taskTask 18045Rated by 20 occupational experts, August 2019
  3. Task 3. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.Core taskTask 18061Rated by 20 occupational experts, August 2019
  4. Task 4. Coordinate, prepare, or review regulatory submissions for domestic or international projects.Core taskTask 18048Rated by 20 occupational experts, August 2019
  5. Task 5. Prepare or maintain technical files as necessary to obtain and sustain product approval.Core taskTask 18062Rated by 20 occupational experts, August 2019
  6. Task 6. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.Core taskTask 18049Rated by 20 occupational experts, August 2019
  7. Task 7. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.Core taskTask 18055Rated by 20 occupational experts, August 2019
  8. Task 8. Coordinate recall or market withdrawal activities as necessary.Core taskTask 18067Rated by 20 occupational experts, August 2019
  9. Task 9. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.Core taskTask 18052Rated by 20 occupational experts, August 2019
  10. Task 10. Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.Core taskTask 18070Rated by 20 occupational experts, August 2019
  11. Task 11. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.Core taskTask 18051Rated by 20 occupational experts, August 2019
  12. Task 12. Identify relevant guidance documents, international standards, or consensus standards.Core taskTask 21094Rated by 20 occupational experts, August 2019
  13. Task 13. Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Core taskTask 18050Rated by 20 occupational experts, August 2019
  14. Task 14. Review clinical protocols to ensure collection of data needed for regulatory submissions.Core taskTask 18065Rated by 20 occupational experts, August 2019
  15. Task 15. Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.Core taskTask 21095Rated by 20 occupational experts, August 2019
  16. Task 16. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.Core taskTask 18058Rated by 20 occupational experts, August 2019
  17. Task 17. Recommend changes to company procedures in response to changes in regulations or standards.Core taskTask 18063Rated by 20 occupational experts, August 2019
  18. Task 18. Participate in internal or external audits.Core taskTask 18060Rated by 20 occupational experts, August 2019
  19. Task 19. Compile and maintain regulatory documentation databases or systems.Core taskTask 18053Rated by 20 occupational experts, August 2019
  20. Task 20. Write or update standard operating procedures, work instructions, or policies.Core taskTask 18066Rated by 20 occupational experts, August 2019
  21. Task 21. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.Core taskTask 18059Rated by 20 occupational experts, August 2019
  22. Task 22. Develop or track quality metrics.Core taskTask 18068Rated by 20 occupational experts, August 2019
  23. Task 23. Develop or conduct employee regulatory training.Core taskTask 18056Rated by 20 occupational experts, August 2019
  24. Task 24. Recommend adjudication of product complaints.Core taskTask 21096Rated by 20 occupational experts, August 2019
  25. Task 25. Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.Supplemental taskTask 19553Rated by 20 occupational experts, August 2019
  26. Task 26. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.Supplemental taskTask 18069Rated by 20 occupational experts, August 2019
  27. Task 27. Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.Supplemental taskTask 18064Rated by 20 occupational experts, August 2019
  28. Task 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 taskTask 19557Rated by 20 occupational experts, August 2019
  29. Task 29. Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.Supplemental taskTask 19552Rated by 20 occupational experts, August 2019
  30. Task 30. Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.Supplemental taskTask 19554Rated by 20 occupational experts, August 2019

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
  1. Published by
    O*NET 29.0, U.S. Department of LaborEmployment and Training Administration
  2. Classification
    Standard Occupational Classification 2018, 13-1041
  3. License
    CC BY 4.0Free to copy and reuse, with credit
  4. Changed by us
    Nothing.

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