Director, Global Regulatory Strategy

Regulatory Toolkit; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

GSK seeks an experienced regulatory leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will provide strategic regulatory leadership for assets, engaging with global and regional teams to shape development programmes and regulatory strategies.

You may serve as Global Regulatory Lead or Regional Regulatory Director, leading strategy and engagement with health authorities across the product lifecycle.

Qualifications

• Bachelor's degree or equivalent in biological/healthcare science or related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.

Responsibilities

• Develop and execute global and regional regulatory strategies for Respiratory, Immunology and Inflammation assets.
• Integrate regulatory strategy with medicines development plans and market requirements.
• Provide strategic regulatory leadership to cross-functional development teams.
• Lead health-authority interactions, regulatory submissions, and milestone meetings.
• Collaborate with clinical development, safety, medical, commercial and local regulatory colleagues.

Skills

Regulatory strategy

Leadership

Cross-functional teams

Regulatory submissions

Education

Bachelor's degree in biological/healthcare science

Job description

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

Position Summary

We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio.

As Director, Global Regulatory Strategy, you will provide strategic regulatory leadership for assigned assets, working across global and regional teams to shape development programmes and deliver effective regulatory strategies. You will operate as a senior individual contributor, bringing regulatory insight, scientific understanding and sound judgement to complex development decisions.

Depending on portfolio needs, you may serve as Global Regulatory Lead or Regional Regulatory Director for selected assets, leading regulatory strategy and engagement with health authorities throughout development and the product lifecycle.

What you’ll do

• Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned Respiratory, Immunology and Inflammation assets.
• Ensure regulatory strategy is integrated with medicines development plans, evidence-generation strategies and the requirements of priority markets.
• Provide strategic regulatory leadership to cross-functional development teams and act as a key point of accountability for assigned assets.
• Assess regulatory precedent, intelligence and the competitive environment to identify opportunities, risks and implications for development strategy.
• Translate complex scientific and regulatory information into clear recommendations that enable timely, well-informed decisions.
• 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 and local regulatory colleagues.
• Develop regulatory approaches that support appropriate labelling based on the available evidence and applicable regulatory requirements.
• Anticipate regulatory risks and develop practical strategies to address them.
• Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
• Represent regulatory perspectives with senior leaders and health authorities, advocating clearly and credibly for evidence-based approaches.
• Contribute regulatory expertise to due-diligence and business-development activities where required.
• Identify opportunities to use digital capabilities and new approaches to strengthen regulatory decision-making and improve efficiency.

Basic qualifications and experience

We are looking for candidates with:

• A bachelor’s degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.