Director, Regulatory Affairs - Vaccines

Overview

Site Name: USA - Maryland - Rockville, Durham Blackwell Street, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

Posted Date: Feb 6 2026

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

You will lead regulatory process improvements and support regulatory activities across the United States. You will work closely with cross-functional teams, external partners, and senior leaders to simplify processes, reduce cycle times, and improve quality. We value curiosity, clear communication, and a practical approach to problem solving. This role offers growth, visible impact, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.

Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.

• Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally
• Implement the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensure appropriate interaction with regional commercial teams in local region
• Ensure compliance with regional requirements at all stages of product life from C2MD
• Advocate persuasively to senior leaders in GSK and in Health Authorities
• Provide assessment of potential in license molecules

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
• Extensive Experience (5+ years) in regulatory affairs across all phases of drug development.
• Proven track record in leading regional development, submission, and approval activities.
• Experience working on clinical trial and licensing requirements in major countries.
• Experience in Vaccines Regulatory Affairs

Preferred Qualification

If you have the following characteristics, it would be a plus:

• PhD in Biological or Healthcare Science.
• Expertise in developing product or therapeutic knowledge in new areas.
• Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.
• Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
• Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.

This position is hybrid with a requirement for regular on-site collaboration. Minimum 2-3 days a week onsite.

We welcome people who bring different perspectives and life experiences. We foster an inclusive environment where you can be yourself, learn, and grow. You will join a team that values transparency, teamwork, and practical progress. If you want to help make medicines and processes better for patients…