Director, Regulatory Affairs CMC, Combination Products and Device

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.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   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.

The Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios, programs, or regulatory domains. This role serves as a strategic thought partner in strategy and execution, to shape development and lifecycle strategy, anticipate regulatory risk, and enable successful global registration and lifecycle management. The Director operates at a strategic level across PDM, Global Regulatory Affairs, Quality, and other cross-functional functions, guiding decisions where regulatory pathways may be complex, evolving, or without clear precedent, while ensuring alignment with business priorities and long-term capability building.

Set and lead global CMC regulatory strategy for complex device and combination product portfolios, programs, or critical regulatory workstreams Shape global regulatory approaches that support product development, registration, lifecycle management, patient supply continuity, and long-term business objectives Serve as a strategic partner with cross-functional team by influencing key development, manufacturing, control strategy, and lifecycle decisions with a clear understanding of regulatory risk and opportunity Lead resolution of complex regulatory issues for combination product and device programs, including areas where regulations are evolving or where explicit precedent may be limited Guide development of regulatory risk mitigation and contingency strategies across major programs and submissions Oversee regulatory strategy and execution for major global submissions, significant post-approval changes, and other critical regulatory milestones (IND/CTA, NDA/BLA/MAA, Notified Body Opinion) Represent CMC Regulatory Affairs during health authority interactions on CMC topics relevant to combination products and device Drive consistent interpretation and implementation of global regulations, standards, and policy trends relevant to devices and combination products, and influence internal approaches accordingly Act as a bridge across global, regional, and functional stakeholders to ensure alignment, transparency, and execution against regulatory priorities Contribute to the strategic direction of combination product and device regulatory capability, including process improvements, knowledge sharing, talent development, and future-facing regulatory practices Participate in external industry forums, conferences, or policy-shaping discussions, as appropriate, to strengthen external insight and help inform Gilead’s regulatory position   QUALIFICATIONS A scientific degree with extensive directly relevant experience in CMC, device or combination product development, and global regulatory affairs