Director, cmc regulatory affairs

Position Summary: You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for small molecule medicines. You will work closely with R&D, supply, quality and commercial colleagues to enable development, approval and uninterrupted supply. You will be a clear decision maker who builds strong partnerships, solves problems with practical solutions, and supports the growth of colleagues. This role offers visible impact, career growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Problem solving and impact: You will direct project activities across multiple programmes and influence decisions at senior levels. You will design practical solutions for complex regulatory challenges, improve CMC regulatory processes, and ensure regulatory positions support business needs while protecting patient supply.

Responsibilities

• Lead CMC regulatory strategy for investigational and early commercial small molecule medicines across global teams.
• Act as the CMC regulatory representative on cross‑functional project and leadership teams.
• Identify regulatory risks and propose clear mitigation plans to senior leadership.
• Mentor and develop regulatory colleagues and, where required, manage a small team.

Basic Qualifications

• Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
• Extensive CMC regulatory experience, including development and manufacturing knowledge.
• Proven experience preparing or contributing to global CMC submissions.
• Strong written and verbal communication skills for internal and external stakeholders.
• Ability to manage multiple projects and meet timelines.
• Experience working with cross‑functional teams (R&D, supply, quality, commercial).

Preferred Qualifications

• 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.
• Practical experience engaging with global regulatory authorities and inspections.
• Track record of mentoring and developing junior colleagues.

Location and Working Pattern

This role is offered as a hybrid role. You will split your time between an agreed GSK site and remote working to support team collaboration and stakeholder engagement. Specific on‑site days will be agreed with your manager.

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.