Assoc Director, Regulatory Affairs CMC

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

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We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

JOB DESCRIPTION

The Associate Director, CMC Regulatory Affairs – Combination Products and Device is responsible for defining and advancing global CMC regulatory strategy for products, platforms, or major workstreams involving devices and combination products. This role ensures that regulatory strategy is integrated into development and lifecycle planning and that submissions are executed in a manner that supports approvability, business objectives, and continuity of supply. The Associate Director acts as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams by translating complex technical, development, and regulatory considerations into clear regulatory pathways, risk-based recommendations, and executable plans.

KEY 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 global 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 cross-functional stakeholders on development pathways, design control considerations, human factors, and lifecycle approaches relevant to regulatory submissions
• Interpret and apply global regulations, guidance, and policy trends to shape regulatory strategies and support successful submissions and approvals
• Lead cross-functional evaluation of regulatory risks, tradeoffs, and mitigation plans, and drive alignment on recommended paths forward
• Partner with global and regional regulatory colleagues to ensure coordinated strategy, strong communication, and market-specific readiness
• Play a lead role in preparation for health authority interactions, including briefing materials, strategic positioning, and responses to agency questions relevant to combination products and devices
• Influence cross-functional stakeholders to anticipate regulatory implications early and incorporate them into development and lifecycle decisions
• Lead or contribute to initiatives that improve regulatory processes, tools, ways of working, and knowledge management across the function
• Support building organizational awareness and knowledge build of combination products and devices, and associated global regulatory landscape

QUALIFICATIONS

• A 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
• Strong knowledge of the global CMC regulatory landscape for devices and combination products, including key market expectations and evolving regulatory trends
• Demonstrated ability to interpret technical CMC and device information and translate it into effective regulatory strategy
• Proven ability to influence cross-functional decision-making and operate as a strategic partner within complex development environments
• Strong communication, presentation, and stakeholder management skills
• Demonstrated ability to lead through ambiguity, manage competing priorities, and guide teams through complex regulatory challenges

ABOUT GILEAD

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. …