Regulatory Affairs Manager, CMC – mRNA Vaccine Development (Hybrid)

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

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Parental leave

Job summary

GSK in the United States is seeking a Regulatory Affairs Manager for CMC in mRNA vaccine development to lead key regulatory activities from late-stage development through lifecycle management.

You will partner with regulatory, manufacturing, quality, and development teams to shape CMC regulatory strategies ensuring compliance and timely approvals. This hybrid role requires proactive communication and a commitment to global health impact.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
• Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.
• Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.
• Advanced degree (Master’s or PhD) in a scientific or regulatory field.

Responsibilities

• Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions.
• Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.
• Collaborate with and provide timely regulatory advice to cross‑functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution.
• Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right‑First‑Time submission readiness.
• Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or related scientific discipline

Advanced degree (Master’s or PhD) in a scientific or regulatory field

Tools

Veeva

Job description

GSK in the United States is seeking a Regulatory Affairs Manager for CMC in mRNA vaccine development to lead key regulatory activities from late-stage development through lifecycle management.

You will partner with regulatory, manufacturing, quality, and development teams to shape CMC regulatory strategies ensuring compliance and timely approvals. This hybrid role requires proactive communication and a commitment to global health impact.