Business IntroductionAt 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.
Position SummaryYou will lead Chemistry, Manufacturing and Controls (CMC) regulatory activities across development, registration, and early lifecycle stages. You will work with cross-functional teams including development, manufacturing, quality, and regulatory colleagues. We value practical problem-solvers who communicate clearly, act with integrity, and put patients at the center. This role offers growth through complex regulatory work, direct impact on supply and access, and a chance to help unite science, technology and talent to get ahead of disease together.
ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Develop and implement CMC regulatory strategies for US and global filings and lifecycle maintenance.
- Prepare, review and maintain CMC components of regulatory submissions and responses.
- Provide clear regulatory advice to cross-functional teams on compliance, risk and readiness for submissions.
- Lead agency interactions and act as a primary contact for regulatory authorities when required.
- Support inspections, quality events and supply continuity through regulatory strategy and documentation.
- Mentor colleagues and contribute to process improvements that raise quality and efficiency.
Basic Qualification
- Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field.
- Minimum 6 years of CMC regulatory affairs experience in the pharmaceutical, biologics, or combination product space.
- Experience preparing and authoring CMC dossier sections for US regulatory submissions.
- Practical knowledge of US regulatory requirements, Good Manufacturing Practices, and relevant ICH guidance.
- Proven ability to work in cross-functional teams and manage multiple projects to meet deadlines.
- Strong written and verbal communication skills with experience communicating technical information clearly.
Preferred Qualification
- Advanced degree (Master’s or PhD) in a relevant scientific discipline.
- Experience leading regulatory interactions with the US Food and Drug Administration.
- Experience with eCTD Module 3 and managing complex submission packages.
- Track record of supporting inspections or major quality events from a regulatory perspective.
- Experience in device-related or combination product regulatory strategy.
- Demonstrated ability to coach and develop junior regulatory colleagues.
Location and Working ModelLocation: London – New Oxford StreetHybrid working is expected with regular on-site presence (typically 2-3 days per week), unless otherwise agreed with the hiring manager.
What you will gainYou will join a team focused on meaningful outcomes for patients. You will grow your technical and leadership skills through hands-on regulatory work. You will influence important decisions that support product quality and supply. We welcome people who bring different perspectives and who commit to an inclusive workplace.
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, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under law.
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