Associate Director, Operational and Digital Enablement, 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.   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. Job Description   At Gilead, our pursuit of a healthier world for all people has led to a cure for hepatitis C, revolutionary advances in HIV treatment and prevention, and progress across viral and inflammatory diseases and certain cancers. We set bold ambitions in our fight against some of the world’s most devastating diseases. We are united by a shared commitment to solving complex public health challenges and improving the lives of patients for generations to come. Gilead is seeking an Associate Director, Regulatory Operations & Digital Enablement to advance operational effectiveness and digital enablement across CMC Regulatory Affairs.     This role will lead and support initiatives focused on business process design and optimization, digital and automation enablement, operational scalability, and effective implementation of new ways of working. The Associate Director will partner across CMC Regulatory Affairs, other PDM functions, Regulatory Affairs, and IT to translate business needs into practical, sustainable process and digital solutions.     The role requires a strong understanding of regulatory operations combined with demonstrated capability in process improvement, digital technologies, data, and change implementation. The successful candidate will be comfortable moving between business problems, process design, technology-enabled solutions, and implementation to improve how CMC Regulatory Affairs operates globally.    Key Responsibilities       Regulatory Operations & Process Improvement   • Lead business process mapping, analysis, design, and optimization initiatives across CMC Regulatory Affairs, including development, registration, post-approval, and lifecycle management activities.  • Identify operational pain points, process gaps, inefficiencies, and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.  • Apply structured problem-solving and data-driven approaches to evaluate root causes, assess options, and develop practical and sustainable solutions.  • Facilitate cross-functional workshops and working sessions to define current and future-state processes, clarify roles and decision points, and establish implementation plans.  • Support the development and maintenance of process standards, procedures, governance mechanisms, and operational controls that enable consistent execution across CMC Regulatory Affairs.  • Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and opportunities for continued improvement  • Support portfolio, resource, and operational planning activi