Associate Director, Regulatory Submission Management

About the role

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.

Regulatory Submission Management (RSM) acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together. As an Associate Director, RSM, you will have a primary focus on regulatory portfolio planning across multiple programs and assigned submissions of increasing complexity. Portfolio planning and submission assignment include, but are not limited to, developing global filing plans, planning and executing original marketing applications across multiple regions, and partnering with the Global Regulatory Lead in aligning the regulatory strategy within the regulatory project teams. You will be responsible for partnering with RA Liaisons and GRAD (Global Regulatory Affiliates and Distributors) in regulatory submissions portfolio planning and oversee the submission execution of the full submission lifecycle as a functional area expert. You will oversee timelines, communications, meetings, and other interactions to ensure submission deliverables are met on time and meet technical specifications per health authority requirements. You will be the Regulatory Submission Management representative within the Submission Team to various partners and stakeholders. You will typically manage multiple major submissions simultaneously. You will also contribute to short- and long-range RSM strategies, plans and infrastructure development. You will lead RSM process improvement activities and lead complex Regulatory initiatives and/or complex Development initiatives. This role does not include responsibilities for regulatory strategy which are led by RA Liaisons and GR