Corcept is seeking a Director of Regulatory Affairs CMC to lead the preparation of CMC Regulatory documents and manage a high-performing regulatory CMC team. The ideal candidate will have 10+ years of experience in Regulatory Affairs in the biopharmaceutical industry and a proven track record of effective collaboration with Global regulatory agencies.
Requirements
- Effectively maintain and motivate a high-performing regulatory CMC team
- Lead regulatory - CMC intelligence activities
- Provide Regulatory CMC guidance to internal teams and lead cross-functional teams
- Assess the regulatory impact of proposed manufacturing process changes
- Track regulatory CMC commitments and manage ongoing regulatory submissions
- Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines
Benefits
- 401k Matching
- Retirement Plan
- Generous Paid Time Off