We are seeking a talented Regulatory Affairs professional with strong knowledge / experience to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team.

This role reports directly to a Director (Team Lead) for Therapeutic Groups (RII).

Job purpose
The Manager / Associate Director ensures the development of appropriate global and regional regulatory strategies and their execution for assigned assets to ensure the development program meets the needs of the key markets identified and the Medicines Profile (and is consistent with the Medicines Development Strategy / Integrated Asset plan).

Key to delivery in this role is ensuring compliance with internal GSK process and policies, as well as with appropriate regulatory requirements to deliver the best possible labelling to meet the Medicine Profile (commensurate with the available data).

Key Responsibilities

• Proactively develop regulatory strategies that 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.
• Manage regulatory interactions and the review processes in local regions.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure compliance with global/regional requirements at all stages of product life.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.

Location
The successful applicant can be based at GSK HQ (London), Wavre (Belgium) or Upper Providence, Durham or Rockville (USA).

About You
This role is a great opportunity to be instrumental in developing and delivering subject matter expertise across GSK. As this role is multi-faceted and includes liaising with a wide variety of key-stakeholders you must have strong experience of working in complex technical situations, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role.

About GSK
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/

Application closing date Monday 7th of December 2026 (COB).

Basic Qualifications

• Degree-educated in relevant scientific or technical discipline (or very strong relevant experience).
• Relevant regulatory affairs experience in the EU and/or US and other major markets. Experience should include, for example, developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes.
• Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
• Ability to develop necessary specialist knowledge for the product or area of medicine.
• Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.

Preferred Qualifications

• Experience of all phases of the drug development process in regulatory affairs.
• Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
• Experience in relevant therapy area (especially Immunology & Inflammation) is a plus.

Work arrangement
This role is hybrid. Regular on-site collaboration is mandatory. Typical schedule will be two to three days on-site per week.

Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.