Director, CMC Regulatory Affairs

Role 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 and professional growth, with the chance to help GSK unite science, technology and talent to get ahead of disease together. Location options include the United Kingdom (Ware, Stevenage or HQ), United States (Waltham, MA or Upper Providence, PA), Belgium (Wavre), Italy (Siena) or Switzerland (Zug), with a hybrid on-site/remote working arrangement.

Responsibilities

• 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.

Skills

• 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.

Qualifications

• Required: Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
• Required: Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
• Preferred: Advanced degree (MSc or PhD) in a relevant scientific discipline.
• Preferred: Experience leading CMC regulatory teams or line management responsibility.
• Preferred: Experience with lifecycle management and post-approval regulatory activities.
• Preferred: Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
• Preferred: Demonstrated success leading major inspections or regulatory interactions.
• Preferred: Practical experience with global regulatory frameworks and agency engagement.
• Preferred: Experience with mentoring junior colleagues
• Preferred: Proven track record preparing or contributing to global CMC submissions.
• Preferred: Experience engaging with cross-functional teams across R&D, supply and quality.
• Preferred: Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
• Preferred: Ability to manage multiple projects, set priorities and meet timelines.