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Regulatory CMC Director

1 month ago

Uxbridge, United Kingdom Bristol Myers Squibb Full time

About the Role:

The Global Regulatory CMC Director will be responsible for developing and implementing global regulatory strategies for cell therapy products, ensuring compliance with current regulations and guidelines.

Key Responsibilities:

  • Represent regulatory CMC on and/or lead matrix teams for cell therapy pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
  • Independently provide strategic guidance/input related to current regulatory requirements and expectation for biologics/cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
  • Independently manage and prioritize multiple complex projects
  • Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
  • Identify, communicate and propose resolutions to routine/complex issues
  • Interpret global regulations and guidance. Identify regulatory opportunity and risks.
  • Anticipate and communicate possible regulatory paradigm shifts
  • Participate in product fact finding meetings
  • Review and provide regulatory assessments on change controls
  • Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents

Requirements:

  • Minimum BA/BS Degree
  • Minimum of 10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 8+ years CMC regulatory strategy (biologics/cell therapy experience preferred).
  • Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred.
  • Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred.
  • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
  • Ability to identify, communicate and resolve complex issues.
  • Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
  • Ability to interpret global regulations and guidance.

About Bristol Myers Squibb:

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are passionate about pioneering innovation to deliver life-changing medicines and therapies to patients with serious diseases.