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. You will collaborate with cross‑functional stakeholders, 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.
Responsibilities
* Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understand, interpret and advise 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.
* Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects.
* Involve 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, acting as an individual contributor or holding direct line management responsibilities as per business needs.
* Hold accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
* Ensure all appropriate CMC regulatory aspects across teams support change control requests, including transfer of supply within GSK or with a third party, delivered to agreed timelines.
Problem Solving skills
* Direct project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provide strategic direction, data assessment and conclusions to senior management.
* Formulate novel approaches and influence people, systems, and processes.
* Identify key risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies to senior management.
* Create, maintain and continually evaluate/improve CMC Regulatory processes, policies, and systems.
* Act as a key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
Qualifications
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 requirements.
Preferred Qualification
* 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 with 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 for interacting with internal stakeholders and regulatory authorities.
* Ability to manage multiple projects, set priorities and meet timelines.
Working Pattern and Location
This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (Upper Providence or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on‑site and remote working. Specific on‑site days will be agreed with your manager to support team collaboration and stakeholder engagement.
Equal Employment Opportunity Statement
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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