Director/Associate Director, Regulatory Affairs CMC
Immunome, Inc.Bothell, Washington, United States
Posted November 7, 2025
164510 - 231000 USD year
Full Time
About the Company
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
Job Description
Immunome is seeking a Director/Associate Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules.
Requirements
- Develop and execute global regulatory CMC strategies across clinical and commercial stages.
- Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality and project teams.
- Author, review and manage the preparation of high-quality CMC sections for regulatory submission.
- Lead interactions with global health authorities on CMC topics.
- Maintain current knowledge of regulations and guidelines.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
