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Director, CMC Regulatory Affairs
GSKDirector of CMC Regulatory Affairs leading strategy for small molecule medicines at GSK. Collaborating with global teams and mentoring regulatory colleagues while managing CMC submissions.
About the role
Key responsibilities & impact- 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.
- Improve CMC regulatory processes and ensure regulatory positions support business needs while protecting patient supply.
Requirements
What you’ll need- 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).
Benefits
Comp & perks- Uniting science, technology and talent to get ahead of disease together.
- Culture of being ambitious for patients, accountable for impact and doing the right thing.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC regulatory strategyregulatory submissionsdevelopment knowledgemanufacturing knowledge
Soft Skills
mentoringteam managementcommunicationproject management