gilead
Sr Manager, Regulatory Affairs CMC, Combination Products and Device
At a Glance
- Location
- United States - California - Foster City, United States
- Work Regime
- hybrid
- Employment
- Full time
- Experience
- 8+ years
- Compensation
- y range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety o
- Posted
- 2026-08-11
Key Requirements
Domain Knowledge
- Manufacturing
- Regulatory
Benefits & Perks
aid time off, and a benefits package. Benefits include company-sponsored med
Requirements
8+ years with BA/ BS
2+ years with PharmD/ PhD
Experience supporting development and submissions management of regulatory filings, including experience leading routine to moderately complex CMC regulatory activities
Working knowledge of global CMC regulatory requirements relevant to devices and combination products
Responsibilities
The Senior Manager, CMC Regulatory Affairs – Combination Products and Device is responsible for supporting CMC regulatory activities for development or lifecycle programs involving devices and combination products.
This role supports the development and implementation of global regulatory strategy and is accountable for execution of high-quality regulatory submissions and lifecycle activities that support clinical development, product registration, and continued market supply.
The Senior Manager partners closely with the Pharmaceutical Development & Manufacturing (PDM) team to ensure global regulatory requirements are incorporated into program planning and execution.
Contribute to the development and implementation of global CMC regulatory strategies for development, registration, and lifecycle management of combination products
Serve as the CMC Regulatory Affairs Combination Product and Device Lead for assigned device and combination product programs or workstreams
Interpret and apply relevant global regulations, guidance, and evolving expectations relevant to devices and combination products to program work and strategy
About the Company
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.