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. This role offers visible impact, career 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 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.
- Direct project activities across multiple programmes and influence decisions at senior levels.
- Design practical solutions for complex regulatory challenges.
- Improve CMC regulatory processes and ensure regulatory positions support business needs while protecting patient supply.
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.
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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