Director, Regulatory Affairs CMC
ProPharmaWaltham, Massachusetts, United States
Posted April 29, 2026
Full Time
About the Company
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success. Our mission is simple: improving patient health and safety by delivering the highest-quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risks and accelerates high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
Job Description
ProPharma seeks a Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies across Dyne's development programs. The role requires a highly experienced regulatory professional to operate independently, influence cross-functional stakeholders, and drive complex regulatory strategies while meeting critical timelines in a fast-paced, dynamic biotech environment.
Requirements
- Bachelor's degree in Life Sciences or a related scientific discipline required
- Minimum of 10+ years of experience in biotechnology or pharmaceutical industry
- At least 7+ years in Regulatory Affairs with strong focus on CMC
- Strong experience supporting global regulatory filings and health authority interactions
- Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
