Director, CMC and Device Regulatory Affairs
Apogee TherapeuticsUnited States
Posted December 16, 2025
220000 - 240000 USD year
Full Time
About the Company
Apogee Therapeutics is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment.
Job Description
Apogee Therapeutics is a biotechnology company seeking a Director, CMC and Device Regulatory Affairs to lead global regulatory CMC strategies for drug-device combination products. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products.
Requirements
- Develop and implement global CMC and device regulatory strategies
- Lead the preparation and review of CMC and device regulatory submissions
- Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams
- Manage interactions with regulatory agencies and notified bodies
- Review CMC-related changes for potential impact on global submissions
- Archive and maintain regulatory submissions and correspondences
- Contribute to the optimization and implementation of processes and procedures
Benefits
- Market competitive compensation and benefits package
- Performance bonus
- Equity grant opportunities
- Health, welfare & retirement benefits
- Competitive time off, including three weeks PTO and two one-week company-wide shutdowns a year