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What is Regulatory Affairs?
Regulatory affairs involves developing and executing strategies for regulatory approval of drugs and medical devices. Physicians in regulatory roles help navigate FDA, EMA, and other regulatory agencies.
Key Responsibilities
- Develop regulatory strategies for drug approval
- Prepare and review IND, NDA, and BLA submissions
- Lead interactions with FDA and other regulatory agencies
- Advise on labeling and promotional materials
- Ensure compliance with regulatory requirements
Common Job Titles
- Regulatory Medical Director
- VP Regulatory Affairs (Medical)
- Global Regulatory Physician
- Regulatory Strategy Lead
Compensation Range
- Entry-level: $220,000 - $300,000
- Mid-level (Director): $280,000 - $380,000
- Senior (VP): $350,000 - $500,000+