Regulatory Head of Intercontinental and Gilead Patient Solutions Affiliates and Distributors

At Gilead, we’re creating a healthier world for all people. For over 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 ensure access worldwide. We continue to fight against major 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 discovering and developing life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions. We’re looking for passionate and ambitious individuals ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are central to the employee experience at Gilead and Kite. As a leader, you will be key 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.

Position Overview

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

This role will define the regulatory team’s vision and strategy for these regions, ensuring alignment with the overall regulatory vision for GRAD, global regulatory affairs, and commercial objectives. It provides strategic direction, leadership, and development of senior regulatory leaders to maximize the impact of the regulatory function in supporting the development, registration, and delivery of medicines to patients.

The position oversees all regulatory activities supporting both development and commercialized products, aiming to optimize speed to market through operational excellence and a robust quality management system. The ideal candidate is passionate about advancing therapeutics and has in-depth knowledge of regulatory affairs in the covered countries, with a successful track record of business-focused regulatory outcomes.

Leading a team of senior professionals, the candidate should have extensive experience in leadership, people management, project management, and guiding large teams to success. The Regulatory Head will be a member of the GRAD leadership team within Global Regulatory Affairs and a key part of the ICR Leadership Team led by the SVP of Commercial for the region.

Key Responsibilities

• Provide leadership and strategic vision for regulatory teams across the region.
• Manage performance, outsourcing, and operational initiatives.
• Develop and manage budgets to meet strategic and operational goals.
• Recruit, develop, motivate, and coach talent, fostering growth and succession planning.
• Promote a culture of collaboration, excellence, and innovation to enable timely, high-quality submissions and approvals.
• Represent regional needs at the GRAD and ICR Leadership Teams.
• Develop operating and resourcing models aligned with business objectives.
• Assess and develop strategies to mitigate regulatory challenges.
• Oversee all regulatory activities, including submissions, advertising, early access programs, and GxP compliance.
• Ensure policies, procedures, and training promote effective operation and compliance with distributor partners.
• Build strong partnerships with stakeholders across functions and regions.
• Ensure adherence to local and international regulatory guidelines and standards.
• Stay current with regulatory trends and contribute to policy development.
• Act as deputy for the Vice President GRAD as needed.

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Proven leadership and team management skills.
• Extensive experience in the pharmaceutical/biotech industry with regional and affiliate roles.
• Deep knowledge of regulatory requirements, including ICH and regional standards.
• Track record in developing regulatory and business strategies and managing negotiations with authorities.
• Experience in legislative updates and technical document review.
• Excellent leadership, planning, organizational, and communication skills.

Gilead Core Values

• Integrity (Doing What’s Right)
• Accountability (Taking Personal Responsibility)
• Equal Employment Opportunity (EEO)

Gilead Sciences is committed to recruiting and employing the most qualified persons without discrimination based on protected characteristics or prohibited grounds by law.

For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Job Requisition ID R0046075

Full Time/Part Time: Full-Time

Job Level: Director