Director of CMC Strategy

5 days ago


London, Greater London, United Kingdom GlaxoSmithKline Full time

About the Role: We are looking for an experienced professional to join our team as a Director of Policy and Regulatory Affairs. This role will be responsible for leading key strategic CMC regulatory activities for investigational and early commercial biological products.

Key Responsibilities:

  • Lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals
  • Provide strategic direction and guidance on both global project and key strategic business initiatives
  • Develop and implement effective CMC regulatory strategies to support major inspections or quality incidents

Requirements:

  • Master's degree in a relevant field (e.g., pharmaceutical sciences, regulatory affairs)
  • Minimum 8 years of experience in CMC regulatory affairs, preferably in a biopharmaceutical industry
  • Proven track record of leading complex projects and teams

What We Offer:

  • A competitive salary range of $150,000 - $200,000 per year
  • A comprehensive benefits package, including medical, dental, and vision insurance
  • A generous 401(k) matching program

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