As Regulatory Manager, Delivery – Licence Maintenance, you will lead the efficient delivery and high quality of CMC (Chemistry, Manufacturing, and Controls) regulatory outputs and licence maintenance activities across GSK’s product portfolios. You will oversee the authoring, review and approval of complex CMC submissions and market-specific requirements, guide cross-functional teams to secure timely regulatory approvals and lifecycle management, and proactively manage risks to achieve optimal regulatory outcomes aligned with GSK’s business objectives. You will also help drive continuous improvement and digital transformation of CMC regulatory processes, strengthening regulatory capabilities and developing subject matter expertise within the team.
We value clear communication, solid digital and data skills, practical problem solving, collaboration and a growth mindset. This role offers the opportunity to shape how we deliver CMC regulatory strategy and licence maintenance globally, while developing yourself and others.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
• Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios by overseeing the authoring, review and approval of high-quality CMC submissions and variations, including market-specific requirements.
• Ensure efficient delivery and high quality of CMC outputs and that effective regulatory processes are followed to assess and assure the quality, reliability and consistency of data used in regulatory submissions.
• Independently manage multiple complex CMC project assignments simultaneously, including planning, tracking and reporting against key milestones and regulatory timelines.
• Coordinate cross-functional inputs from CMC Regulatory Affairs, Global Supply Chain, local operating companies, quality, manufacturing and external partners to produce submission-