Hybrid CMC Regulatory Lead for mRNA Vaccine Development

GlaxoSmithKline; Waltham (MA); Hybrid; USD 114,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Healthcare & wellbeing

Pension plan

Share-based incentives

Remote/Hybrid work

Job summary

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development in a hybrid US role (Upper Providence PA, Rockville MD, Waltham MA or Durham NC). You will lead CMC regulatory activities, coordinating with regulatory, manufacturing, quality and development teams to ensure timely approvals and global conformity.

The role requires a Bachelor’s in a life sciences field, 2+ years in CMC regulatory affairs for vaccines or biologics, and 1+ year in CMC submission readiness for US/EU

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 contributing to CMC sections for US/EU submissions.

Responsibilities

• Develop and execute CMC regulatory strategies for vaccine products (Module 3/2.3) aligned with US and global requirements.
• Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA) and early lifecycle changes.
• Collaborate with cross-functional teams (manufacturing, quality, development) to support CMC strategy and flawless execution.
• Plan and track 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

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor's degree in life sciences/related field

Tools

Veeva

Job description

GSK is seeking a Regulatory Affairs Manager in CMC for mRNA vaccine development in a hybrid US role (Upper Providence PA, Rockville MD, Waltham MA or Durham NC). You will lead CMC regulatory activities, coordinating with regulatory, manufacturing, quality and development teams to ensure timely approvals and global conformity.

The role requires a Bachelor’s in a life sciences field, 2+ years in CMC regulatory affairs for vaccines or biologics, and 1+ year in CMC submission readiness for US/EU