Manager, CMC Vaccines Mature Projects, Regulatory Affairs

4w4 weeks ago

GSK

US · Full-time · $113,850 – $189,750

About this role

You will lead Chemistry, Manufacturing and Controls (CMC) regulatory activities for mature vaccine projects. You will work with regulatory, development, quality, and manufacturing colleagues to ensure compliant submissions and supply continuity. We value clear communicators who are collaborative, pragmatic, and focused on patient impact.

You will prepare, review, and quality-check CMC content for regulatory submissions, variations, and maintenance filings. You will coordinate global dossier assembly, review cycles, and responses to regulatory questions. You will advise cross-functional teams on regional regulatory requirements and their impact on project timelines.

GSK has bold ambitions for patients, aiming to positively impact the health of 2.5 billion people. Our R&D focuses on discovering and delivering vaccines, combining understanding of the immune system with cutting-edge technology. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing.

This role offers visible influence on product lifecycle and professional growth. You will have the chance to help GSK unite science, technology, and talent to get ahead of disease together. We are uniting science, technology, and talent to get ahead of disease together.

Requirements

Bachelor’s degree in pharmacy, chemistry, biotechnology or related scientific discipline, or equivalent experience.
2+ years’ experience in CMC regulatory affairs or pharmaceutical/biopharmaceutical development with direct involvement in regulatory submissions.
Experience preparing or contributing to lifecycle submissions and post-approval regulatory activities.
Knowledge of CMC requirements for vaccines or biologics and of regulatory dossier formats.
Prior experience working with cross-functional teams including quality, manufacturing, and clinical development.

Responsibilities

Lead CMC regulatory planning and execution for mature vaccine projects and lifecycle activities.
Prepare, review and quality-check CMC content for regulatory submissions, variations, and maintenance filings.
Coordinate global dossier assembly, review cycles, and responses to regulatory questions.
Advise cross-functional teams on regional regulatory requirements and their impact on project timelines.
Support supply continuity by ensuring regulatory requirements for manufacturing, release and distribution are in place.
Contribute CMC subject matter expertise and share best practices to improve regulatory processes.

Benefits

Visible influence on product lifecycle decisions
Professional growth opportunities within a leading pharmaceutical company
Chance to contribute to GSK's mission to positively impact the health of 2.5 billion people