Associate Director, CMC Regulatory Affairs (Devices & Combos)

Regulatory Jobs; Foster City (CA); Hybrid; USD 182,000 - 236,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. is seeking an Associate Director, CMC Regulatory Affairs – Combination Products and Device in Foster City, CA.

This role defines and advances global CMC regulatory strategy for devices and combination products, ensuring regulatory strategy is embedded in development plans and submissions support approvability and supply continuity. The position partners with PDM and cross-functional teams to translate technical and regulatory considerations into clear pathways and executable

Qualifications

• Minimum qualifications describe years of experience with BA/BS, MS, or PhD.
• Experience leading development and submission management of regulatory filings.

Responsibilities

• Define and lead global CMC regulatory strategy for device and combination product programs.
• Integrate regulatory strategy into cross-functional program plans and supply considerations.
• Oversee global regulatory planning for complex submissions and post-approval changes.

Skills

CMC Regulatory Strategy

Device & Combination Product Knowledge

Global Regulatory Affairs

Cross-functional leadership

Education

BA/BS in a relevant field

MA/MS/MBA in a relevant field

PharmD/PhD

Job description

Gilead Sciences Inc. is seeking an Associate Director, CMC Regulatory Affairs – Combination Products and Device in Foster City, CA.

This role defines and advances global CMC regulatory strategy for devices and combination products, ensuring regulatory strategy is embedded in development plans and submissions support approvability and supply continuity. The position partners with PDM and cross-functional teams to translate technical and regulatory considerations into clear pathways and executable