Director, Global Regulatory CMC Cell Therapy

Posted 2 days ago
Main Location
New York City, NY, United States
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The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle.  Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities.

Position Summary / Objective

The CMC Regulatory Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy  products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions.

In this role, the GRS-CMC Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Global Product Supply (GPS). The GRS-CMC Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.

Position 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 cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
  • Review and provide 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
  • Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
  • 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
  • Mange relationships with diverse teams
  • Utilize electronic systems for dossier creation and tracking.

Experience / Requirements

  • Minimum BA/BS Degree with 8-10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 5-7  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 multi-functional teams, handle and prioritize multiple projects and work independently.
  • Ability to interpret global regulations and guidance.
  • Strong oral and written skills. Ability to identify, communicate and resolve complex issues.
  • Proficient with electronic systems
  • Minimal travel will be required

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.


Mission
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Director, Global Regulatory CMC Cell Therapy
Bristol Myers Squibb