Regulatory CMC Manager – mRNA Vaccines (Hybrid)

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

Benefits offered by this job

Annual bonus

Health care

Pension plan

Employee shares

Hybrid/Remote work

Job summary

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

The role is hybrid within the United States (Upper Providence, PA; Rockville, MD; Waltham, MA; Durham, NC) with on-site engagement required to drive submissions and compliance.

Qualifications

• Bachelors degree in life sciences, pharmacy, chemistry, biotechnology, or related field.
• 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.

Responsibilities

• Development and execution of CMC 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.
• Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelors degree in life sciences, pharmacy, chemistry, biotechnology, or related field

Tools

Veeva

Job description

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

The role is hybrid within the United States (Upper Providence, PA; Rockville, MD; Waltham, MA; Durham, NC) with on-site engagement required to drive submissions and compliance.