Director, CMC Regulatory Affairs

Position Summary
You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products, working across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply.

Responsibilities
- Lead CMC regulatory strategy for investigational and early commercial biological products across global teams; advise on regulations, guidelines, procedures, policies and strategies for development, registration and manufacturing to expedite global CMC applications.
- Serve as a key strategic partner for Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
- Own submission content; ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
- Support in-licensing and divestment projects with CMC regulatory support/advice.
- Identify regulatory risks and propose 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 individual contributor or may have line management responsibilities.
- Ensure information submitted in marketing applications meets regional requirements while enabling manufacturing flexibility and innovation and ensuring approvability.
- Deliver CMC regulatory aspects for change control requests, including supply transfers within GSK or with a 3rd party, to agreed timelines.

Problem Solving Skills
- Direct project activities/strategies for multiple projects and teams; provide strategic direction, data assessment and conclusions to senior management.
- Formulate novel approaches and influence people, systems, and processes.
- Identify key risks tied to submission data/information packages and communicate risk mitigation strategies.
- Create, maintain and continually improve CMC Regulatory processes, policies and systems.
- Design and/or implement new and improved procedures to set standards and improve efficiency and quality.

Qualifications
Required
- Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
- Extensive CMC regulatory experience in biopharmaceuticals, including development and manufacturing requirements.

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

How to apply
- Submit a short cover letter or summary explaining how your experience fits the role and why you are interested.