Ph3Senior Manager, GRA CMC Vx Mature Product /h3 p5 days ago Be among the first 25 applicants /p pbSite Name: /b Italy - Siena, Belgium-Wavre, Poznan Grunwaldzka, UK – London – New Oxford Street /p pbPosted Date: /b Nov 3 2025 /p pbLocations: /b Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland /p pAt 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 RD 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. /p h3Scope /h3 pThis role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross‑functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail‑oriented, and skilled at navigating complex regulatory environments. /p h3In this role, you will: /h3 ul liDevelop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards. /li liPrepare and review technical regulatory documents to support submissions and lifecycle management. /li liProvide regulatory advice to cross‑functional teams, including RD, manufacturing, and quality assurance. /li liLead discussions with regulatory authorities and represent the company in external engagements. /li liIdentify risks and propose mitigation strategies to ensure smooth regulatory processes. /li liMentor and train team members, fostering a culture of continuous improvement. /li /ul h3Basic Qualifications /h3 ul liBachelor’s degree in life sciences, pharmacy, chemistry, or a related field. /li liSolid and proven experience in CMC regulatory affairs. /li liStrong knowledge of global CMC regulatory requirements and drug development processes. /li liProven ability to manage multiple projects and meet deadlines. /li liMust be fluent in English (both written and spoken). /li /ul h3Preferred Qualifications /h3 ul liMaster’s degree or PhD in a relevant scientific discipline. /li liRegulatory Affairs Certification (e.g., RAPS). /li liExperience leading teams and managing complex regulatory submissions. /li liTrack record of effective negotiation with regulatory agencies. /li liExcellent communication and collaboration skills. /li liProficiency in French is a plus. /li /ul h3What We Offer /h3 ul liPermanent contract in a very inclusive environment. /li liSmart Working up to 50% for eligible roles. /li liPerformance Reward. /li liFlexible Benefits. /li liCompany Healthcare Plan. /li liIntegrative pension fund. /li liEmployee Assistance Programme. /li liPrevention services and vaccination clinic. /li liTax assistance. /li liLocal nursery agreement. /li liPostal service, laundry, shoe repair and tailoring. /li liOn Site Gym. /li liOn Site canteens and coffee corners. /li liFree company bikes and shuttle. /li /ul pRelocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered. /p pClosing Date for Applications – 9 November 2025 /p h3Closing Date for Applications – 9 November 2025 /h3 h3Why GSK? /h3 pUniting science, technology and talent to get ahead of disease together. /p pGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. /p pPeople and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. /p pIf you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at (US Toll Free) or (outside US). /p pGSK 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. /p /p #J-18808-Ljbffr