Regulatory CMC Manager - mRNA Vaccine Development (Hybrid)

GSK; Durham (NC); Hybrid; USD 114,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Healthcare and wellbeing programs

Pension plan membership

Shares and savings programme

Remote or hybrid work model

Job summary

GSK is seeking a Regulatory Affairs Manager (CMC) for mRNA vaccine development products, partnering with regulatory, manufacturing, quality and development teams to shape CMC strategies ensuring compliance and timely approvals.

You will contribute to late-stage development through early lifecycle management, with opportunities to influence global health and advance your career within a hybrid US-based role.

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, biotechnology, or related field.
• 2+ years in CMC regulatory affairs, with vaccine/biologics exposure.
• 1+ year preparing CMC sections for US/EU regulatory submissions.

Responsibilities

• Develop and execute CMC regulatory strategies for vaccine products (Module 3/2.3).
• Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA, early life cycle variations).
• Provide timely regulatory advice to cross-functional CMC workstreams (manufacturing, quality, development).
• Track CMC source documents and dossier sections to ensure readiness for submissions.
• Identify regulatory risks and propose mitigation plans to keep projects on track.
• Support team members and share best practices in CMC regulatory affairs.

Skills

CMC regulatory affairs

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

FDA/EU knowledge

Education

Bachelor's degree in life sciences or related field

Tools

Veeva

Job description

GSK is seeking a Regulatory Affairs Manager (CMC) for mRNA vaccine development products, partnering with regulatory, manufacturing, quality and development teams to shape CMC strategies ensuring compliance and timely approvals.

You will contribute to late-stage development through early lifecycle management, with opportunities to influence global health and advance your career within a hybrid US-based role.