Director, Regulatory Affairs

Director, Regulatory Affairs

Gilead

Dublin, Ireland

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.

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 of regulatory mechanisms to optimise pediatric product development (e.g., Orphan Drug Designation, Fast Track Designation, conditional/accelerated approval, and compassionate use);
• Proactively identify and assess pediatric regulatory risks, including compliance, timing, and execution risks, and work with cross-functional and regulatory partners to define mitigation strategies and address challenges;
• Collaborate with regulatory and cross-functional teams through effective communication and strong regulatory leadership to prepare and coordinate the execution of global pediatric strategies and plans in support of corporate and regulatory goals, align approaches across programmes and therapeutic areas, and incorporate key learnings;
• As needed, 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.

REQUIREMENTS

We are all different, yet we all use our unique contributions to serve patients.

Please see below the qualifications and skills we are seeking for this role.

Education & Experience

• 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 is strongly preferred;
• Pharmaceutical industry experience within Regulatory Affairs is strongly preferred;
• Experience across one or more Gilead therapeutic areas and different stages of drug development is strongly preferred.

Knowledge & Skills

• Thorough understanding of pediatric regulatory requirements, including ICH guidelines and regional requirements for major markets, as well as current global and regional Regulatory Affairs trends, with the ability to assess their impact on the business;
• Excellent verbal, written, influencing, negotiation, and interpersonal communication skills;
• Proven ability to manage complex projects, balancing multiple priorities and deliverables through influence and leadership;
• Strong analytical and problem-solving capabilities, demonstrated through professional experience;
• Strong leadership skills with experience guiding, influencing, and leading others towards shared goals.