Director, CMC Regulatory Affairs

GSK•Upper Providence, PA

3d•Hybrid

About The Position

This role leads global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for small molecule medicines. The position involves close collaboration with R&D, supply, quality, and commercial colleagues to facilitate development, approval, and uninterrupted supply. The company values individuals who are clear decision-makers, build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers significant impact, career growth opportunities, and the chance to contribute to GSK's mission of uniting science, technology, and talent to get ahead of disease.

Requirements

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).

Nice To Haves

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.

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.