Director, Cmc Regulatory Affairs

GlaxoSmithKline

Ware, United Kingdom
Base: $173,250 to $288,750; bonus/equity: annual b...
Hybrid
Extensive cmc regulatory experience in biopharmaceuticals
Degree in biological sciences or related field
Experience with development and manufacturing requirements
GSK is seeking a Director of CMC Regulatory Affairs to lead global regulatory strategy for complex biological products, ensuring compliance and facilitating development and approval processes. The role emphasizes partnership across teams and offers significant professional growth opportunities within a culture committed to patient impact

Job Summary

  • This role leads global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products across R&D, supply, quality, and commercial teams.
  • The position offers visible impact, professional growth, and the chance to help GSK unite science, technology, and talent to get ahead of disease together.
  • Available benefits include health care, retirement benefits, paid holidays, vacation, and eligibility for an annual bonus and share-based long-term incentive program.

Matching Summary

Match Score: 85

GSK is seeking a Director of CMC Regulatory Affairs to lead global regulatory strategy for complex biological products, ensuring compliance and facilitating development and approval processes. The role emphasizes partnership across teams and offers significant professional growth opportunities within a culture committed to patient impact.

Salary

Base: $173,250 to $288,750; Bonus/Equity: Annual bonus and share-based long term incentive program; Benefits: Health care, retirement, paid holidays, vacation, parental leave

Skills & Requirements

Must-have

  • Extensive CMC regulatory experience in biopharmaceuticals
  • Degree in biological sciences or related field
  • Experience with development and manufacturing requirements

Nice-to-have

  • Advanced degree in relevant scientific discipline
  • Experience leading CMC regulatory teams
  • Experience with cell and gene therapies
  • Proven track record preparing global CMC submissions
  • Strong written and verbal communication skills

Key Requirements

  • Degree in biological sciences, chemistry, pharmacy, engineering
  • Extensive CMC regulatory experience in biopharmaceuticals
  • Line management responsibility preferred

Work Rights

Not specified

Tailored Resume

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