Senior Regulatory Affairs Scientist

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)