Exec Director, Regulatory Affairs

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. 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. 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. 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.

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 in-market Regulatory Heads and distributor hub leads across the regions. The ICR region includes: Affiliates in Korea, Taiwan, Hong Kong, Singapore, Brazil, Mexico, Colombia, Saudi Arabia, Turkey and Russia. 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 will also need to maintain close connection with the regulatory heads for China and Japan (reporting to the Vice President of GRAD) to ensure top level understanding of development and filing activities.

This role will define 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 the commercial objectives of the regions. In addition, the role 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. This position will oversee all regulatory activities in the region in support of both development and commercialised products ensuring regulatory input and direction provided throughout the product lifecycle. A primary aim being 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 together with a history of successful business focused regulatory outcomes.

Leading a team of senior regulatory professionals, the successful candidate will also have extensive experience in leadership, people management, project management and a robust track record of guiding large teams to success. The Regulatory Head of Intercontinental and Gilead Patient Solutions (GPS) will be a member of the GRAD leadership team within Global Regulatory Affairs and will be a key member of the ICR Leadership Team led by the SVP of Commercial for the region.

Key Responsibilities:

• Provide leadership of the Regulatory teams across the region including setting strategic vision and direction.
• Provide effective management oversight including but not limited to 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 ensuring 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 optimizing their effectiveness 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 needed.
• Develop and maintain an operating and resourcing model to deliver on business objectives.
• In partnership with the 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 cross-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.

Qualifications:

• 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 understand current global and regional trends in regulatory affairs and 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 impact many departments.
• Experience in critically reviewing complex technical documents and influencing colleagues across functions.
• Excellent leadership, planning and organisational skills.
• Excellent verbal & written English, negotiation, influence, and interpersonal communication skills.

The role is based in the UK. We are pleased to share that Gilead's Stockley Park and Holborn offices are planning to come together at a new London headquarters at 1 Triton Square, NW1, from approximately Q2 2027. Applicants should consider this planned location change when applying for this role. Gilead operates a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.