Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence

<p>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.<br/> </p><p>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.<br/> </p><p>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.<br/><br/><b>Job Description</b><br/> </p><p><span>Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organization and acts 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 in obtaining and maintaining licensure of Gilead's medicinal products and proprietary methodologies and technologies by managing registrations, other filings and regulatory agency communications and interactions in our key markets around the world.</span></p><p></p><p><span>Gilead's Pediatric Center of Excellence is a global hub in Dublin, Ireland, dedicated to advancing research and development of treatments for children with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer.  You will act as the Franchise Lead for </span>Regulatory Affairs at the Pediatric Center of Excellence<span>. You will </span>provide leadership and mentorship for your direct reports by <span>oversee</span>ing and guiding <span>the development and execution of regulatory strategies, plans and objectives for pediatric development</span> of products and compounds across the Virology, Oncology and Inflammation therapeutic areas in alignment with and within the overall global development of a product<span>. </span>This may include overseeing the development of global pediatric regulatory plans and preparation of pediatric regulatory submissions, monitoring the progress and completion of global pediatric commitments, and guiding and advising colleagues in the thorough and compliant completion of these activities. You may act as the Global Regulatory Lead and/or the serve as a Gilead contact to / for regulatory authorities as needed.</p><p></p><p><span>As </span><b><span>Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence</span></b><span>, you will act as a senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams. You will play a leadership role on regulatory leadership teams, at the Pediatric Center of Excellence and in ad hoc or special projects/initiatives that seek to continuously improve or advance GRA capabilities. </span></p><p></p><p><u><b>RESPONSIBILITIES: </b></u></p><ul><li><p>Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology and Inflammation TAs to achieve strategic milestones and objectives.</p></li><li><p>Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons and cross-functional teams to ensure alignment with broader product development goals, driving efficiency and enhancing organizational capabilities.</p></li><li><p>Represents Gilead in negotiations with regulatory authorities as needed.</p></li><li><p>Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans.</p></li><li><p>Manages one or more direct reports.</p></li><li><p>Provides accurate and thorough input and recommendations into resource plans required to complete deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.</p></li><li><p>Ensures own work complies with established practices, policies and processes, and any regulatory o