Senior Manager, Vaccines CMC RA

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

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.

- 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.

Qualifications/Skills

Basic
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field.
- At least 6 years of 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.
- Excellent communication and collaboration skills.

Preferred
- 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.
- Fluency in English; proficiency in French is a plus.

Work Location
This role is based in Belgium and offers a hybrid working model, combining on-site and remote work flexibility.

Join us in shaping the future of vaccines and making a meaningful impact on global health.

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK 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. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People 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.

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