Regulatory Affairs Manager, CMC – mRNA Vaccines (Hybrid)

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 114,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Healthcare

Pension plan

Shares and savings programme

Remote/hybrid working model

Job summary

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development to lead regulatory activities from late-stage development through early lifecycle management. You will partner with regulatory, manufacturing, quality and development teams to shape CMC strategies and ensure timely approvals.

This hybrid role is based in the United States across multiple sites, with on-site collaboration required.

Qualifications

• Bachelor's degree in life sciences or related field required.
• Minimum of 2 years of experience in CMC regulatory affairs with vaccine/biologics exposure.
• Experience contributing to CMC sections of regulatory submissions (US/EU).

Responsibilities

• Develop and execute CMC regulatory strategies for vaccine products (Module 3/2.3) aligning with US and global requirements.
• Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA) and consultations.
• Provide timely regulatory advice to cross‑functional CMC workstreams (manufacturing, quality, development).
• Contribute to planning of CMC source documents and dossier sections for Right-First-Time 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

Regulatory strategy

Cross-functional collaboration

Regulatory compliance

Communication

Strategic leadership

Education

Bachelor's degree in life sciences, pharmacy, chemistry, biotechnology, or related

Tools

Veeva

Job description

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development to lead regulatory activities from late-stage development through early lifecycle management. You will partner with regulatory, manufacturing, quality and development teams to shape CMC strategies and ensure timely approvals.

This hybrid role is based in the United States across multiple sites, with on-site collaboration required.