Regulatory Affairs Specialists

A typical week, in the words of people in the job

1. 01Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
2. 02Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
3. 03Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
4. 04Coordinate efforts associated with the preparation of regulatory documents or submissions.
5. 05Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
6. 06Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
7. 07Prepare or maintain technical files as necessary to obtain and sustain product approval.
8. 08Coordinate recall or market withdrawal activities as necessary.
9. 09Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
10. 10Develop regulatory strategies for products.
11. 11Identify relevant guidance documents, international standards, or consensus standards.
12. 12Coordinate, prepare, or review regulatory submissions for domestic or international projects.

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