Regulatory Project Manager, CMC Regulatory Affairs

At GSK, we are seeking a Regulatory Project Manager, CMC Regulatory Affairs to lead and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams. 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

• 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.

Benefits

• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver/parental and medical leave