Manager, Regulatory Affairs CMC
Kite PharmaSanta Monica, California, United States
Posted May 5, 2026
133195 - 172370 USD
Full Time
About the Company
Kite Pharma is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
Job Description
Join Kite, a biopharmaceutical company, as a Manager, Regulatory Affairs CMC to support the development of innovative cancer immunotherapies. This role will provide regulatory CMC leadership for global clinical development and commercial expansion across multiple regions.
Requirements
- Lead all operational and lifecycle management aspects of Regulatory CMC submissions
- Serve as the Regulatory CMC lead on assigned program and/or platform teams
- Author, review, and coordinate Module 3 (M3) content
- Develop and execute CMC regulatory strategies
- Proactively identify CMC regulatory risks and lead scenario planning
- Support interactions with global health authorities
- Collaborate cross-functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
Benefits
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- 401k Matching