Director Regulatory Affairs CMC
About the role
This is a high-impact role where you’ll take ownership of CMC regulatory strategy across both development and commercial programs, operating as the lead for key assets. You’ll be working closely with cross-functional teams across development, manufacturing and quality, playing a central role in driving products through to approval and lifecycle management.
Responsibilities
- Shaping global CMC regulatory plans across the full product lifecycle
- Direct involvement in major submissions such as INDs, BLAs and MAAs
- Supporting Health Authority interactions, guiding programs through critical regulatory milestones
- Anticipating and managing regulatory risks
- Supporting change control and compliance activities
- Helping keep programs on track globally
Requirements
The ideal candidate will have a strong background in Regulatory CMC within pharma or biotech, typically around 10+ years, with experience supporting major global submissions. They should be comfortable working in a matrixed environment, able to balance strategy with detail, and confident operating across technical and leadership teams.
Qualifications
PhD in a relevant field or equivalent experience, with a minimum of 10 years of experience in Regulatory CMC within pharma or biotech. Experience supporting major global submissions is essential.
Skills
Strong strategic thinking and execution skills, ability to work in a matrixed environment, and confidence in leading cross-functional teams are crucial. Proficiency in regulatory processes and familiarity with health authority interactions are also important.
Benefits
Good visibility across the organization, with the opportunity to influence senior stakeholders and contribute to broader program strategy, not just execution.
Pay
TBD
Schedule
TBD