Director, CMC Regulatory Affairs
Hybrid · Ware, England, United Kingdom or Upper Providence, Pennsylvania, United States
Job Summary
Lead global 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. You will 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.
Required 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)
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