Director, Global Regulatory Affairs, Pediatrics

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 fulfill their aspirations. Join Gilead and help create possible, together. Job Description   JOB DESCRIPTION Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organisation and serves as a critical strategic partner across drug discovery, development, and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential to securing and maintaining licensure for Gilead's medicinal products, proprietary methodologies, and technologies by managing registrations, regulatory filings, and agency communications and interactions across key markets worldwide. Gilead's Pediatric Center of Excellence is a global hub based in Dublin, Ireland, dedicated to advancing the research and development of treatments for children living with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer. The Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation therapeutic areas, aligned with the overall global development strategy for each product. This may include overseeing the development of global pediatric regulatory plans and submissions, monitoring the progress and fulfilment of global pediatric commitments, and guiding and advising colleagues to ensure these activities are completed thoroughly, effectively, and compliantly. The successful candidate will collaborate across multiple functions and partner with global and regional regulatory leaders to explore and advance the use of our medicines as potential treatments for children living with serious diseases. This role requires the successful candidate to be based in our Dublin office. We will consider suitably qualified candidates from other countries who express an interest, with the understanding that relocation to Dublin would be required and would not be supported by Gilead. RESPONSIBILITIES • Accountable for developing, maintaining, and delivering the global pediatric regulatory strategy in alignment with the overall development of a product. • Provide leadership on pediatric regulatory requirements in major markets (e.g., United States and European Union) and strategic pediatric regulatory guidance in support of global pediatric development and submissions, including the use