Director, Cmc Regulatory Affairs

GSK

Ware, United Kingdom
Base: $173,250 to $288,750 (us); bonus/equity: ann...
Hybrid
Extensive cmc regulatory experience in biopharmaceuticals
Degree in biological sciences or related field
Experience with development and manufacturing requirements
This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products at GSK

Job Summary

  • This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products at GSK.
  • The position requires advising cross-functional networks on regulations to expedite submission, review, and approval of global CMC applications.
  • GSK offers a hybrid working model with competitive compensation including an annual bonus and eligibility for share-based long-term incentives.

Matching Summary

This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products at GSK.

Salary

Base: $173,250 to $288,750 (US); 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 (MSc or PhD) in scientific discipline
  • Experience leading CMC regulatory teams
  • Experience with cell and gene therapies
  • Demonstrated success leading major inspections
  • 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

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