Director, Regulatory Affairs, 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.

Find out more:

[Our approach to R&D](https://www.gsk.com/en-gb/innovation/)

Position Summary

We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organization, supporting our Oncology portfolio. As Director, Global Regulatory Strategy, you will provide strategic regulatory leadership for assigned oncology assets, working across global and regional teams to shape development programs and deliver innovative, effective regulatory strategies. You will operate as a senior individual contributor, bringing deep regulatory insight, strong scientific understanding and sound judgement to complex oncology development decisions. Depending on portfolio needs, you may serve as Global Regulatory Lead or Team Lead for selected assets, leading regulatory strategy and engagement with health authorities throughout development, registration and the product lifecycle.

What you’ll do

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• Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned oncology assets and development programs.
• Ensure regulatory strategy is integrated with medicines development plans, clinical development and evidence-generation strategies, and the requirements of priority markets.
• Provide strategic regulatory leadership to cross-functional oncology development teams and act as a key point of accountability for assigned assets.
• Assess regulatory precedent, intelligence and the competitive oncology landscape to identify opportunities, risks and implications for development strategy.
• Translate complex scientific, clinical and regulatory information into clear recommendations that enable timely, well-informed development decisions.
• Develop regulatory strategies that consider the unique complexities of oncology drug development, including accelerated or expedited development pathways, novel clinical-development approaches, biomarker-driven strategies and companion diagnostics, where applicable.
• Lead regulatory matrix teams and coordinate delivery of regulatory activities across functions and geographies.
• Lead health-authority interactions, regulatory submissions, milestone meetings and review processes.
• Partner effectively with clinical development, safety, medical, commercial, biomarker, diagnostics and local regulatory colleagues.
• Develop regulatory approaches that support appropriate labelling based on the available clinical evidence and applicable regulatory requirements.
• Anticipate regulatory risks and emerging issues and develop practical strategies to address them.
• Ensure compliance with applicable regulatory requirements throughout development and the product lifecycle.
• Represent regulatory perspectives with senior leaders and hea...

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