Regulatory Project Manager, CMC Regulatory Affairs

GSK•Waltham, MA

4d•$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. Find out more: Our approach to R&D Position Summary You will lead and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams. You will work with colleagues in regulatory, development, quality, and manufacturing to shape regulatory strategy and deliver high-quality submissions. We value clear communicators who are curious, collaborative, and focused on practical solutions. This role offers growth, visible impact on product development, and alignment with GSK’s mission to 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 in pharmaceutical/biopharmaceutical development with direct involvement in regulatory submission preparation.

Nice To Haves

Advanced degree in a relevant scientific or regulatory field.
Experience with vaccines or biologics
Experience preparing or managing global submissions and interactions with regulatory agencies.
Familiarity with regulatory requirements across major regions (for example United States and European Union).
Experience supporting post-approval lifecycle activities and manufacturing changes.
Proven ability to influence stakeholders and negotiate technical-regulatory issues.
Comfort with process improvement and driving efficiencies in regulatory operations.
Practical knowledge of CMC requirements for clinical and commercial submissions.
Experience working in cross-functional teams and managing competing priorities.
Strong written and verbal communication skills with attention to detail.
Ability to work independently and collaboratively in a matrix environment.

Responsibilities

Lead CMC regulatory planning and execution for assigned projects, adapting to shifting priorities.
Develop CMC regulatory strategies and prepare or coordinate submission documents from clinical phase to lifecycle management.
Advise cross-functional teams on regulations, guidance and regional requirements to support timely submissions.
Coordinate global dossier assembly, review cycles and responses to regulatory questions.
Support supply continuity by ensuring regulatory aspects for manufacturing and release are in place.
Share best practices, support continuous improvement, and contribute to CMC subject matter expertise.
Manage timelines, deliverables and stakeholders for CMC regulatory activities.
Work closely with development, manufacturing and quality teams to align technical and regulatory approaches.
Prepare, review and quality-check CMC content for regulatory filings and maintenance submissions.
Track regulatory changes and help interpret their impact on project plans and submissions.
Coordinate interactions with external partners and regulatory authorities as needed.
Support inspections and provide regulatory input for manufacturing or process changes.