Site Locations: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street

Posted Date: Jul 16 2025

Manager, CMC Vaccines Development Projects

Job Purpose:

As a Manager, CMC Vaccines Development Projects, you will be responsible for CMC regulatory activities across the investigational, development, and commercial lifecycle of our products.

Key Responsibilities:

1. Drive the CMC strategy and coordinate the preparation and review of technical (CMC) regulatory documents to support development, registration, and lifecycle management of vaccines, ensuring compliance with regulatory and scientific standards.
2. Provide regulatory guidance to Technical Development, Life-Cycle Teams, and other committees; support R&D, Quality Control, Manufacturing, QA, and Supply functions; collaborate with Global Regulatory teams to define filing strategies.
3. Lead CMC regulatory discussions with worldwide regulatory authorities.
4. Maintain regulatory compliance, share best practices, and promote continuous improvement within the CMC Regulatory teams.
5. Engage and lead CMC Subject Matter Expert activities internally and externally, advocating for compliance and regulatory environment shaping.
6. Mentor or train staff, with potential line or team management responsibilities.
7. Support corporate evaluations, in-licensing, and divestment projects with CMC regulatory expertise.
8. Develop strategies for major inspections and quality incidents.

Qualifications & Experience:

Basic:

• Bachelor's/Master's in Chemistry, Pharmacy, Biological Sciences, or related field.
• Regulatory Affairs Certification (e.g., RAPS).
• Knowledge of drug development, manufacturing, supply processes, and complex CMC regulatory requirements.
• Proven project management, multi-tasking, and influencing skills.

Preferred:

• Extensive experience in pharmaceutical industry or research organizations, with team leadership.
• Active in global regulatory affairs, with a focus on emerging trends and policies.
• Recognized as a CMC regulatory expert.
• Strong interpersonal, presentation, and communication skills.
• Experience supervising and training staff.

Application Deadline: August 8, 2025

Note: Please retain a copy of this Job Description as it will not be available after the posting closes.

#LI-Hybrid

If you require assistance during the selection process due to a disability, please inform us of your needs to make appropriate arrangements.

Why GSK?

GSK is committed to uniting science, technology, and talent to combat disease and improve global health. We focus on vaccines, medicines, and innovative data technologies across key therapeutic areas. Our success depends on our people—creating an inclusive, inspiring environment where everyone can thrive and grow.

Important Notice: GSK does not accept unsolicited referrals from employment agencies without prior written approval. All agency referrals must be authorized beforehand; otherwise, GSK is not liable for any fees.