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)