CMC Regulatory Lead — Devices & Combination Products

Gilead Sciences Inc.; Foster City (CA); Hybrid; USD 182,000 - 236,000; Full time

Job summary

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

This role defines and advances global regulatory strategy, ensuring integration into development plans and submissions that support approvability and supply continuity. You will partner with PDM and cross-functional teams to translate complex technical and regulatory considerations into executable regulatory plans, while aligning with evolving global

Qualifications

• Scientific degree with directly relevant professional experience in CMC, device or combination product development, and global regulatory affairs.
• 10+ years with BA/ BS; 8+ years with MA/ MS/ MBA; 5+ years with PharmD/ PhD.
• Significant experience leading development and submission management of regulatory filings ranging from routine to highly complex.

Responsibilities

• Define and lead global CMC regulatory strategy for device and combination product programs across development, registration, and lifecycle management.
• Ensure regulatory strategy is integrated into cross-functional program plans and aligned with business objectives, development milestones, and supply considerations.
• Lead global regulatory planning and oversight for complex submissions and post-approval changes involving device and combination product content (IND/CTA, NDA/BLA/MAA, Notified Body Opinion).
• Provide strategic regulatory advice to PDM stakeholders on development pathways, design control considerations, human factors, and lifecycle approaches relevant to regulatory submissions.
• Interpret and apply global regulations and policy trends to shape regulatory strategies and support successful submissions.
• Lead cross-functional evaluation of regulatory risks and mitigation plans; drive alignment on recommended paths forward.
• Partner with global/regional colleagues to ensure coordinated strategy and market readiness.
• Play a lead role in preparation for health authority interactions, including briefing materials and agency responses.
• Influence cross-functional stakeholders to anticipate regulatory implications early and incorporate them into development decisions.

Skills

Regulatory strategy

Cross-functional collaboration

Strong communication

Education

BA/BS in a relevant field

MA/MS/MBA

PharmD/PhD

Job description

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

This role defines and advances global regulatory strategy, ensuring integration into development plans and submissions that support approvability and supply continuity. You will partner with PDM and cross-functional teams to translate complex technical and regulatory considerations into executable regulatory plans, while aligning with evolving global