Senior Manager, GRA CMC Vx Mature Product
Descrizione dell'offerta
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.
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
Closing Date for Applications – 9 November 2025
Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.
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.
If 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).
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