CMC Regulatory Manager — mRNA Vaccine Development

Women In Bio; Collegeville (PA); Hybrid; USD 114,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Annual bonus

Pension plan

Employee stock/SHARE program

Job summary

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development. You will lead key regulatory activities, partnering with regulatory, manufacturing, quality and development teams to shape CMC strategies and ensure timely approvals.

You will drive submission readiness and risk mitigation while collaborating across sites in the US, enhancing global health impact and advancing your regulatory career within a dynamic, mission-driven environment.

Qualifications

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

Responsibilities

• Development and execution of CMC regulatory strategies for vaccine products, aligned with US and global requirements.
• Prepare, review, and check CMC documentation for regulatory submissions and consultations.
• Collaborate with cross-functional teams to support RA CMC strategy and execution.
• Track CMC source documents and dossier sections for Right-First-Time submissions.
• Identify regulatory risks and propose mitigation plans.

Skills

Regulatory strategy

CMC

Vaccine regulatory

Cross-functional

FDA meetings

ICH guidance

Education

Bachelor's degree in life sciences/regulatory

Advanced degree preferred

Tools

Veeva

Job description

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development. You will lead key regulatory activities, partnering with regulatory, manufacturing, quality and development teams to shape CMC strategies and ensure timely approvals.

You will drive submission readiness and risk mitigation while collaborating across sites in the US, enhancing global health impact and advancing your regulatory career within a dynamic, mission-driven environment.