Overview

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

Locations: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland

Scope

This 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.

In this role, you will:

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
• Prepare and review technical regulatory documents to support submissions and lifecycle management.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
• Lead discussions with regulatory authorities and represent the company in external engagements.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications:

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
• Solid and proven experience in CMC regulatory affairs.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proven ability to manage multiple projects and meet deadlines.
• Must be fluent in English (both written and spoken).

Preferred Qualifications:

• Master’s degree or PhD in a relevant scientific discipline.
• Regulatory Affairs Certification (e.g., RAPS).
• Experience leading teams and managing complex regulatory submissions.
• Track record of effective negotiation with regulatory agencies.
• Excellent communication and collaboration skills.
• Proficiency in French is a plus.

Note on relocation: relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

Closing Date for Applications – 9 November 2025

Internal applicants may apply through the Workday system by the stated date. The posting is open to all eligible employees and temporary staff per company policy. Applications will be considered only if the candidate is in the current role for at least 12 months. Applications via Workday only.

The offered position level will reflect the candidate’s competence and experience relative to the responsibilities of the role.

Please inform your supervisor when you are invited for the interview.

What we offer: see below in the Benefits section.

What We Offer

• Permanent contract in a very Inclusive environment
• Smart Working up to 50% for eligible roles
• Performance Reward
• Flexible Benefits
• Company Healthcare Plan
• Integrative pension fund
• Employee Assistance Programme
• Prevention services and vaccination clinic
• Tax assistance
• Local nursery agreement
• Postal service, laundry, shoe repair and tailoring
• On Site Gym
• On Site canteens and coffee corners
• Free company bikes and shuttle

GSK Equal Opportunity Employer

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, military service or any basis prohibited under federal, state or local law.

Important notices

GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies are required to contact GSK to obtain prior written authorization before referring candidates. In the event of an interview, GSK may be required to capture and report expenses where applicable under US transparency requirements. For more information, please visit the CMS Open Payments data site.