Director, CMC Regulatory Affairs

Overview

Site Name: UK - Hertfordshire - Ware RD, Belgium-Wavre, GSK HQ, Italy - Siena, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

Posted Date: Jan 30 2026

Business Introduction:
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.

Position Summary:

You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. We value clear decision makers who build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

• Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications.
• Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
• Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK.
• Identify regulatory risks and propose clear mitigation plans to senior leadership.
• Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
• Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
• Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
• Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.

• Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management.
• Formulates novel approaches and influences people, systems, and processes.
• Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
• Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems.
• Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.

Basic Qualification

• Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
• Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing…