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Senior Director - Regulatory CMC

Company: bluebird bio
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Driven by our commitment to patients, bluebird bio's Regulatory Science team partners with colleagues and global regulatory authorities to pioneer access to innovative, safe and effective gene and cell therapies for severe genetic diseases and cancer. Join bluebird bio's enthusiastic and collaborative team and contribute to the success of our novel gene therapy approach as we transform the landscape of medical practice. HOW YOU'LL FLY As a Regulatory Affairs bird reporting to our VP, Regulatory, you'll help to bring more patients their bluebird days by:

  • Partnering with global health authorities and developing creative & innovative strategies that progress current thinking on regulatory requirements related to CMC aspects of cell and gene therapies
  • Providing regulatory CMC strategic leadership to support development and registration of multiple innovative gene therapy products for the treatment of severe genetic disease
  • Leading, mentoring and growing a team of regulatory CMC professionals
  • Directing and overseeing teams responsible for delivering high-quality CMC related clinical trial and marketing applications
  • Ensuring that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures, scientific advice/meeting requests, agency briefing documents, and marketing applications are complete, well written, and meet all relevant requirements
  • Leading negotiations with regulatory agencies to resolve CMC issues and engage in proactive and collaborative interactions with regulators; prepare, review and approve strategies for responding to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
  • Partnering with cross-functional partners including, but not limited to, Technical Development and Operations, Quality, Nonclinical, Clinical and regional and global Regulatory leadership, manage resources for projects, including ensuring adequate regulatory and CMC resources, skills, and budgets are available.
  • Effectively communicating regulatory CMC strategy, risks, mitigations, and overall plans to regional and global regulatory leadership team, project team, and senior management, external partners, as relevant.
  • Driving adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
  • Assessing proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
  • Contributing to regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to various internal teams and external partners as necessary WHAT YOU'LL BRING You're the bird we're looking for if you:
    • Masters' degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree, such as a PhD is desirable
    • 12+ years of relevant biopharmaceutical industry experience, with 10+ years' experience in CMC-focused Regulatory Affairs for biologics or 5+ years' experience in CAGT/ATMPs
    • Prior experience and a successful track record within the biotechnology and/or pharmaceutical industry in preparation and submission of clinical trial and marketing applications, post-approval life cycle management and supporting GMP inspections
    • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA and FDA guidelines
    • Detail oriented; science-based reasoning skills and demonstrated ability to break down complex, scientific content into logical components
    • Excellent written and communication skills, strong technical knowledge, including CMC regulatory writing and ability to influence across multiple functions
    • Strong leadership qualities including strategic thinking, innovation, people management, mentoring, scaling and collaboration
    • Ability to execute and follow-through to completion and documentation
    • Ability to work independently as well as 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
    • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment

Keywords: bluebird bio, Cambridge , Senior Director - Regulatory CMC, Executive , Cambridge, Massachusetts

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