Senior Director, Regulatory Affairs
Formation BioNew York, New York, United States • Boston, Massachusetts, United States
Posted October 9, 2025
300000 - 350000 USD year
Full Time
About the Company
Formation Bio is a tech-driven pharmaceutical company focused on optimizing clinical drug development through innovative technology. The company accelerates trial design, completion, and data quality to develop drugs faster, aiming to expedite patient access to new treatments and maximize value per program. Formation Bio's unique platform sets it apart by enhancing efficiency in the pharmaceutical industry.
Job Description
Formation Bio is a tech-driven AI company focused on accelerating drug development. They are seeking a Senior Director of Regulatory Affairs to lead the regional regulatory strategy for the company’s assets. The role involves developing and implementing regulatory strategies, providing guidance to internal teams, and liaising with regulatory agencies. The position requires a leader who is knowledgeable of regulations and the biopharmaceutical landscape.
Requirements
- BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent experience.
- 10-20 years of Regulatory Affairs experience.
- Experience in the biopharmaceutical industry, including clinical, non-clinical and CMC aspects.
- Strong competency in understanding regulatory requirements.
- Ability to read, analyze and interpret scientific and technical information.
- Experience with biologics and/or small molecule products.
Benefits
- Equity
- Comprehensive benefits
- Hybrid flexibility
