Senior Associate, Regulatory Affairs

Job Summary

Senior Associate, Regulatory Affairs is a full-time position responsible for planning, tracking, and executing U.S. regulatory submissions to the FDA for investigational and commercial products, requiring prior Regulatory Affairs experience.

Key Responsibilities

• Coordinate preparation and execution of U.S. regulatory submissions (INDs, NDAs, BLAs) 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 U.S. regulatory submissions

Required Qualifications

• BA/BS degree in a scientific or health-related discipline or 3+ years of Regulatory Affairs experience
• Experience with CTD/eCTD and document publishing in Adobe Acrobat Professional
• Understanding of FDA structure and regulatory guidance
• Ability to manage multiple U.S. submissions and priorities simultaneously
• Demonstrated ability to function as a trusted partner in a matrixed regulatory environment