Manager, CMC Vaccines Mature Projects, Regulatory Affairs

GSK•Rockville, MD

7d•$113,850 - $189,750•Hybrid

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. This role offers visible influence on product lifecycle, professional growth, and the chance to help GSK unite 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.

Nice To Haves

Master's or PhD degree in a relevant scientific or regulatory field.
Direct experience with vaccine development or biologics CMC regulatory strategy.
Experience managing global submissions and interactions with major regulatory agencies.
Experience supporting inspections and providing regulatory input for manufacturing or process changes.
Familiarity with regulatory requirements across major regions such as the United States and European Union.
Track record of driving process improvements or efficiencies in regulatory operations.
Strong written and verbal communication skills with attention to detail.

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.