Head, Vaccines Development Projects - CMC Regulatory Affairs

Role Summary

Head, Vaccines Development Projects - CMC Regulatory Affairs. Lead CMC regulatory activities for GSK's vaccine development products, directing strategy and ensuring regulatory approvals across clinical trials and global marketing applications. Collaborate with cross-functional teams to deliver complex projects and advance vaccine development in alignment with regulatory requirements.

Responsibilities

• Leads and oversees the development and execution of Vaccine CMC Regulatory strategies, ensuring alignment with GSK‚Äôs goals and regulatory requirements.
• Establishes and directs agency communications including End of Phase 2, Pre BLA, Scientific advice, and ad-hoc product-specific dialogues.
• Ensures risk assessments are conducted with defined mitigation plans, liaising with Product Development, Commercial Supply Chain, GRA and other teams.
• Provides representation and input to product-specific inspections for CMC aspects to secure approvals and drive continuous improvement.
• Directs global teams interfacing with CMC Development and commercial supply organizations for global development products, including licensed assets.
• Manages direct agency interface for CMC aspects of all development and in-licensed assets, negotiating CMC agreements on behalf of R&D CMC Development and the Commercial Supply Chain.
• Manages budget and resources for the department.
• Liaises with heads of CMC Regulatory Development Projects and with mature Products organization to ensure integrated regulatory strategy as products move toward commercial supply.
• Manages, coaches, and mentors staff across CMC RA.

Qualifications

• Bachelor‚Äôs degree in life sciences, pharmacy, or a related field.
• Extensive experience in vaccine physical product development, CMC regulatory affairs, or related areas.
• Extensive expertise across diverse market environments and requirements; ability to assimilate new requirements and establish optimized global approaches.
• Strong understanding of CMC regulatory requirements and processes for vaccine development.
• Extensive development experience including roles within product development and strong regulatory agency interfacing skills.
• Experience managing teams and budgets effectively.
• Excellent communication and interpersonal skills with the ability to influence across diverse teams.

Preferred Qualifications

• Advanced degree (e.g., PhD, MBA) in a relevant field.
• Experience managing vaccine development projects from early-stage research to commercialization.
• Knowledge of global regulatory trends and emerging policies in vaccine development.
• Ability to drive innovation and process improvement in a complex organization.
• Experience engaging with external stakeholders, including regulatory agencies and industry groups.
• Strong leadership with focus on developing and mentoring teams and leaders.

Education

• Bachelor‚Äôs degree in life sciences, pharmacy, or related field (required).
• Advanced degree preferred (PhD, MBA).

Additional Requirements

• Work Arrangement: This role is based in Belgium, Italy, Poland, UK or USA and requires on-site presence with flexibility for hybrid working arrangements.