Manager, Regulatory Affairs CMC
Gilead Sciences · Philadelphia, PA +3 more
The apply link worked recently (not employer-confirmed).
Role summary
Kite seeks a Manager of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) to support regulatory submissions and strategy for cell therapy and lentiviral vector programs. This office-based or hybrid role involves coordinating cross-functional teams, managing regulatory filings, and ensuring compliance with global requirements across multiple U.S. locations.
What they're looking for
- Bachelor's degree with six years of experience, or Master's degree with four years of experience
- Foundational knowledge of CMC regulatory requirements and ICH guidelines
- Working knowledge of lentiviral vector manufacturing, process controls, and analytical characterization
- Understanding of regulatory expectations for viral vector comparability and control strategy development
- Strong written and verbal communication with attention to detail and organizational skills
- Ability to manage multiple priorities and collaborate effectively across functions
What you'll be doing
- Prepare and support CMC regulatory filings including INDs, CTAs, BLAs, and supplements for cell therapy and lentiviral vector programs
- Develop Module 3 content aligned with global regulatory requirements for cell and gene therapies
- Coordinate with cross-functional teams to assess manufacturing changes and their regulatory impact
- Support health authority interactions including preparation of responses to information requests and meeting materials
- Maintain regulatory records and contribute to inspection readiness activities for manufacturing facilities
Privacy & handoff
This role links to Gilead Sciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.