Description
Senior Regulatory Affairs Scientist
Location: Hybrid
Job Type: Full-Time
About the Role
Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products.
Key Responsibilities
- Develop and execute regulatory strategies and submission plans
- Prepare and submit INDs, NDAs, BLAs, and IDEs
- Serve as primary liaison with FDA and regulatory agencies
- Provide regulatory guidance to cross-functional teams
- Monitor regulatory trends and ensure compliance with evolving requirements
- Review and approve regulatory documentation
Requirements
Qualifications
- Advanced degree in regulatory science, biology, or related field
- 8+ years of regulatory affairs experience
- Strong knowledge of FDA regulations and ICH guidelines
Preferred
- RAC certification
- Experience with electronic submissions (eCTD)