Key Duties
- Lead regulatory strategy for pharma and drug-device combination products from development through post-market stages
- Prepare and review INDs, NDAs, supplements, and other regulatory filings
- Act as main liaison with FDA CDER, supporting agency meetings and regulatory communications
- Support global submissions, assess regulatory impact of changes, and mentor junior RA team members
Qualifications & Experience
- 5+ years of Regulatory Affairs experience within pharma, biotech, or combination products
- Strong background with FDA CDER submissions including INDs, NDAs, and supplements
- Proven success managing FDA interactions and executing regulatory strategies
- Experience with drug-device combination products and related FDA requirements is required