Senior Director, Global Regulatory Strategy- Oncology

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology and talent to get ahead of disease together. Our approach to R&D propels us forward.

The Senior Director, Global Regulatory Strategy – Oncology is responsible for developing and executing regulatory strategies for assigned assets in alignment with medicine development and integrated evidence strategies. This role helps ensure development programs support priority market needs, target medicine profiles, applicable regulatory requirements, and internal GSK policies and processes. The role may include direct or indirect people leadership and may also include Global Regulatory Lead responsibilities for one or more assigned assets.

• Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
• Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy.
• Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs.
• Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross‑functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data.
• Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable.
• Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations.
• Provide regulatory input into due diligence, business development, or portfolio‑level assessments, as needed.
• Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams.
• Partner with senior stakeholders to support portfolio‑level strategy, resource planning, operating model development, and delivery of longer‑term objectives or large‑scale initiatives.
• Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross‑functional partners.

Work arrangement:
Hybrid, with regular presence at a U.S. site for leadership activities and key meetings. Remote‑first candidates may be considered if located in the United States and able to travel as required.

• Bachelor's degree in Biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 10+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
• 7+ years of experience supporting drug development programs spanning multiple phases of clinical development.
• 5+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology
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• Experience leading or serving as the regulatory lead for at least one major regulatory submission, approval, or significant lifecycle management submission with a Health Authority.
• Experience leading Health Authority interactions, including preparation, execution, and follow‑up activities related to regulatory milestone meetings.
• Experience working on cross‑functional development teams, including Clinical, Safety,…