What do regulatory affairs specialists do?
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.
This describes a U.S. occupation, not a live vacancy. Individual employers may use different titles and requirements.
Job titles to recognize in your search
O*NET reports these titles for this occupation. Compare the responsibilities in each posting before treating titles as equivalent.
- Drug Regulatory Affairs Specialist
- QA Specialist (Quality Assurance Specialist)
- RA Analyst (Regulatory Affairs Analyst)
- RA Associate (Regulatory Affairs Associate)
- RA Consultant (Regulatory Affairs Consultant)
- RA Strategist (Regulatory Affairs Strategist)
- Regulatory Consultant
- Regulatory Services Consultant
Core tasks to compare with a job posting
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate recall or market withdrawal activities as necessary.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Prepare an application for this occupation
- Check the employer’s requirements, location, schedule and any licenses against your situation.
- Choose two or three tasks above that match the posting and your actual experience.
- Build a resume evidence worksheet using the skills and software relevant to that employer.
- Practice explaining your contribution, decisions and results before an interview.
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