Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence

About the Role

The Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence will serve as the Pediatric Regulatory Lead for assigned products and develop regulatory strategies and plans for pediatric development across Virology, Oncology, and Inflammation, aligned with the overall global development strategy. This role collaborates with cross-functional and regulatory leaders to advance pediatric development and submissions, ensuring compliance with regulatory requirements and timely delivery of pediatric commitments. The Pediatric Center of Excellence in Dublin, Ireland, serves as a global hub dedicated to advancing pediatric treatments for serious diseases. What You'll Do

• Develop, maintain, and deliver the global pediatric regulatory strategy in alignment with product development.

• Provide leadership on pediatric regulatory requirements in major markets (US and EU) and strategic guidance for global pediatric development and submissions, including use of Orphan Drug Designation, Fast Track Designation, conditional/accelerated approvals, and compassionate use.

• Proactively identify and assess pediatric regulatory risks, and work with cross-functional partners to define mitigation strategies.

• Collaborate with regulatory and cross-functional teams to prepare and coordinate global pediatric strategies and plans, align approaches across programmes and therapeutic areas, and incorporate learnings.

• Represent Gilead in negotiations with regulatory authorities and lead the preparation of regulatory documents, presentations, and discussions for Health Authority meetings.

• Lead with an enterprise mindset and initiate or contribute to global and/or local process improvements and corporate or departmental initiatives.

• Ensure compliance with established practices, policies, processes, and all applicable regulatory requirements.

• Work under consultative direction towards corporate regulatory goals and objectives. What We're Looking For

• Education: PharmD/PhD, MA/MS/MBA, or BA/BS with significant relevant experience.

• Experience in pediatric drug development is highly desirable, with direct hands-on experience in regulatory procedures and documentation required for pediatric submissions in key regions such as the US and EU.

• Experience developing and leading regulatory strategies through to successful outcomes.

• Pharmaceutical industry experience within Regulatory Affairs.

• Experience across one or more Gilead therapeutic areas and different stages of drug development.

• Knowledge: Thorough understanding of pediatric regulatory requirements, including ICH guidelines and regional requirements for major markets, as well as current global and regional regulatory requirements.