What are the responsibilities and job description for the Senior Director Regulatory CMC position at Regulatory Connect?
Senior Director of Regulatory Affairs CMC / Head of Reg CMC
MA based - 2 days in the office (not rigid)
Are you ready to lead regulatory CMC strategies for innovative therapies? Join a dynamic biopharmaceutical team tackling rare disease.
About the Role
As Senior Director of Regulatory Affairs CMC / Head of RA CMC, reporting to the Head of RA , you’ll drive global CMC regulatory strategies, ensuring clinical and market access for cutting-edge products. From submission leadership to compliance oversight, your expertise will guide key development phases and life cycle management.
Key Responsibilities
- Develop and execute domestic / global RA CMC strategies and submissions.
- Lead preparation of CMC content for INDs / IMPDs / CTAs, and NDAs / MAAs.
- Collaborate with global health authorities and manage regulatory interactions.
- Monitor FDA / ICH guidelines and share insights with internal teams.
What You’ll Need