Regulatory Affairs Manager, CMC mRNA Vx Development Products

GSK•Waltham, PA

6d•$113,850 - $189,750•Hybrid

About The Position

As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead regulatory activities guiding products from late-stage development through early lifecycle management. Working with cross-functional regulatory, manufacturing, quality, and development teams, you will help shape CMC regulatory strategies to support compliance and timely approvals. The role focuses on U.S. regulatory expectations and global requirements, mainly in Europe and Japan, and includes regulatory submissions and health authority interactions. This hybrid position is based in the United States in Upper Providence, Pennsylvania; Rockville, Maryland; Waltham, Massachusetts; or Durham, North Carolina. Regular onsite work and collaboration with colleagues across U.S. sites and regions are expected. GSK describes its culture as ambitious for patients, accountable for impact, and committed to doing the right thing. GSK offers a competitive salary, an annual performance-based bonus, healthcare and wellbeing programs, pension or retirement benefits, and a shares and savings program. The role also offers eligibility for a share-based long-term incentive program, paid holidays, vacation, insurance benefits, and paid caregiver, parental, and medical leave. For specified U.S. locations, the posted annual base salary range is $113,850 to $189,750.

Requirements

Bachelor’s degree or higher in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
At least 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.
At least 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the U.S. and EU markets for biologicals and/or vaccines.

Nice To Haves

Advanced degree (Master’s or PhD) in a scientific or regulatory field.
Knowledge of U.S. and global regulatory requirements, including FDA regulations, GMP, and ICH guidelines for biologicals or vaccines.
Experience collaborating across regulatory, manufacturing, quality, and development functions.
Awareness of AI tools and interest in applying them responsibly to improve the efficiency or quality of regulatory affairs deliverables.
Experience preparing regulatory interactions and negotiations, including FDA Type C or pre-BLA meetings, CHMP scientific advice, and/or PMDA consultations.
Ability to develop and implement CMC strategies for complex vaccine or biologics products while managing priorities and deadlines in a dynamic environment.
Familiarity with electronic submission formats and systems such as Veeva.
Experience supporting regulatory inspections and providing input on manufacturing or process changes.

Responsibilities

Develop and execute CMC (Module 3/2.3) regulatory strategies for vaccine products in alignment with U.S. expectations and global requirements, mainly Europe and Japan, including health authority interactions.
Prepare, review, and check CMC documentation for regulatory submissions, including IND/CTA, BLA/MAA/JNDA, early lifecycle variations, and consultations.
Provide timely regulatory advice to cross-functional CMC workstreams and matrix teams, including manufacturing and quality, to support strategy development and execution.
Help plan and track CMC source documents and dossier sections to ensure Right-First-Time submission readiness.
Identify regulatory risks and propose mitigation plans to support project progress and successful submissions.
Support team members, continuous improvement, and sharing best practices in CMC regulatory affairs.