Exec Director, Regulatory Affairs

Regulatory Head of Intercontinental (ICR) and Gilead Patient Solutions (GPS) Affiliates and Distributors reporting to the Vice President of Global Regulatory Affiliates and Distributors (GRAD), the Regulatory Head will lead the in-market Regulatory Heads and distributor hub leads across the regions. ICR region includes Affiliates in Korea, Taiwan, Hong Kong, Singapore, Brazil, Mexico, Colombia, Saudi Arabia, Turkey and Russia, and distributor markets Argentina, Chile, Uruguay and the Gulf region. GPS includes an affiliate in South Africa and distributor markets across Africa, South and South East Asia, Middle East, Central Asia and Latin America including Central America and the Caribbean.

This role defines the regulatory team vision and strategy for the ICR and GPS regions ensuring alignment with the overall regulatory vision for the GRAD, Global Regulatory Affairs, and commercial objectives of the regions. It provides strategic direction, leadership, and development of senior regulatory leaders to maximise the impact of the GRAD function in supporting the development, registration and delivery of life‑saving medicines to patients. The position oversees all regulatory activities in the region in support of both development and commercialised products, ensuring regulatory input and direction throughout the product lifecycle. The primary aim is to optimise speed to market through operational excellence underpinned by a robust quality management system.

The ideal candidate is passionate about advancing therapeutics, has an in-depth knowledge of regulatory affairs for the countries covered by the ICR/GPS region, a history of successful business‑focused regulatory outcomes, and experience in leadership, people management, project management and guiding large teams to success. This role is a key member of the GRAD leadership team within Global Regulatory Affairs and of the ICR Leadership Team led by the SVP of Commercial for the region.

• Provide leadership of the Regulatory teams across the region including setting strategic vision and direction.
• Provide effective management oversight including performance management, outsourcing, and operational excellence initiatives.
• Develop and manage budgets effectively to achieve commercial strategic and operational objectives.
• Recruit, retain, develop, motivate, and coach talent, fostering professional growth to ensure the organization evolves to be a leading team in industry and to establish a strong succession pipeline.
• Contribute to a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities to enable timely, high quality local submissions through to approvals.
• Represent the IC/GPS Affiliate and Distributor needs at the GRAD Leadership Team and at the ICR Leadership Team led by Commercial and other teams as required.
• Develop and maintain an operating and resourcing model to deliver on business objectives.
• In partnership with Global Regulatory Affairs Therapy Area Groups, assess and develop strategies to mitigate regulatory challenges associated with product development and commercialised products across the ICR and GPS regions.
• Oversee all regulatory activities in ICR and GPS markets including development and maintenance of procedures, all types of submissions, Advertising and Promotion activities, Early Access Programs and GxP compliance.
• Ensure policies, procedures and training in place to ensure effective operation and compliance of our distributor partners in IC/GPS.
• Form strong, collaborative partnerships with key stakeholders across Regulatory Affairs, CMC Regulatory, Safety, Quality and other functions including General Managers (GMs) and above country GMs across the regions and regional ICR and GPS x-functional partners and leadership, to advance near-term regulatory goals and broader enterprise level objectives.
• Ensure all processes and submissions adhere to local and international regulatory guidelines, laws, and standards.
• Stay current with regulatory trends, changes, and requirements related to international regulatory affairs and contribute to international policy development.
• Act as a deputy for the Vice President GRAD, as required.

• Bachelor’s degree in a relevant field; advanced degree (e.g., MBA, PhD) preferred.
• Proven leadership experience and skills, with the ability to inspire and mentor a diverse and global team.
• Proven experience in the pharmaceutical/biotechnology industry in regional roles and working with affiliates.
• Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements, and an understanding of current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business.
• A strong track record in developing and implementing regulatory and business strategies and managing complex negotiations with regulatory authorities.
• Experience in taking a leadership role in updating and preparing the Company for major changes in legislation which impacts many departments.
• Experience in critically reviewing complex technical documents and influencing colleagues across functions.
• Excellent leadership, planning and organisational skills.
• Excellent verbal communication skills.