Senior Director, Regulatory Science, CMC

Cambridge, MA

bluebird bio is looking for a Director/Sr. Director, Regulatory Science, CMC who will be responsible for providing regulatory CMC strategic leadership.  You will support multiple gene therapy development projects in the US and internationally in the early and late stage of development. In this role you will lead, develop, and build a team that will represent the function of regulatory CMC on project teams and will oversee regulatory CMC submissions across projects.

About the role:

  • Provide regulatory CMC strategic leadership to support development of multiple innovative gene therapy products for the treatment of cancer and rare diseases
  • Lead the regulatory CMC team to successfully file high-quality regulatory CMC submissions prepared in collaboration with regulatory, quality and CMC colleagues
  • Manage, develop, and build a team of experienced professionals in a very collaborative environment
  • Support regulatory CMC team in planning, writing and reviewing CMC sections for MAAs, BLAs, INDs, CTAs, as well as responses to agencies and briefing documents
  • Ensure compliance with CMC regulatory requirements in the US and EU and anticipate CMC regulatory requirements for future commercial filings
  • Ensure that CMC‐related applications, are complete, well‐written, and meet all relevant regulatory requirements for the development of gene therapy products
  • Participate in discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally
  • Support Quality and CMC team during GMP inspections
  • Assess regulatory impact of proposed manufacturing process changes
  • Lead regulatory CMC intelligence activities

 

About you:

 

  • Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required; PhD degree desirable
  • 10 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused Regulatory Affairs preferably for biologics
  • Recent experience with CMC‐related regulatory interactions and BLA/MAA filings
  • Excellent written and oral communication
  • Strong knowledge of current Good Manufacturing Practices (GMP)
  • Thorough understanding of relevant drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
  • Thrive in a fast‐paced environment combining strategic and tactical capabilities
  • Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.
  • Detail oriented; science-based reasoning skills
  • Experience in the field of gene or cell therapy desirable
  • Ability to execute and follow-through to completion and documentation
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated and solution oriented
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

 

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