Senior Associate Regulatory Affairs

Job Summary

Experienced regulatory professionals will find a full-time remote opportunity as a Senior Associate Regulatory Affairs, responsible for planning, tracking, and executing U.S. regulatory submissions to the FDA for investigational and commercial products, including IND, NDA, and BLA filings.

Key responsibilities:

• Coordinate the preparation and execution of U.S. regulatory submissions in compliance with FDA regulations
• Draft and review regulatory submission documents to ensure accuracy and completeness
• Serve as the primary execution lead and cross-functional coordinator for assigned regulatory submissions

Required qualifications:

• BA/BS degree in a scientific or health-related discipline with 2+ years or 5+ years of Regulatory Affairs experience
• 3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA)
• Hands-on support of U.S. IND preparation and knowledge of NDA submissions
• Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools
• Understanding of FDA structure and ICH regulatory guidance and regulations