About the role
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)