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Manager, Regulatory Strategy

Company: bluebird bio
Location: Somerville
Posted on: January 16, 2023

Job Description:

The Regulatory flock is all about making a profound impact on people living with rare diseases through teamwork, strategic conviction, operational focus, and individual accountability to the mission of establishing gene therapy as a meaningful option for patients.The Manager in Regulatory Science will be responsible for supporting major marketing applications in the US as well as managing submissions of investigational new drug application (IND) amendments, biologics license application (BLA) amendments and clinical trial applications (CTAs) amendments.
You'll help to bring more patients their bluebird days by:

  • Collaborating with regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including BLA and BLA amendments; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
  • Assisting in coordination and preparation for regulatory agency meetings and associated briefing document preparation,
  • Managing and reviewing regulatory submissions to ensure compliance with applicable regulations (e.g., IND/CTA amendments, DSURs, Annual Reports, Investigator Brochure, Protocols, Investigator 1572s etc.)
  • Preparing submission plans and manage timelines for regulatory submissions
  • Managing regulatory submission process, documentation, submission logs and archiving
  • Acting as primary regulatory liaison with Clinical Teams and external CROs to manage the conduct of clinical trials including managing the Trial Master File and maintaining clinical trial postings
  • Reviewing technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines, and internal style guidelines and requirements including SOPs
  • Participating in regulatory intelligence activities; monitor regulatory guidelines and trends

    You're the bird we're looking for if you have:

    • BA/BS degree in biochemistry, chemistry, biology or related pharmaceutical fields including bio-chemical engineering, advanced degree preferred
    • 2+ years of regulatory experience in a biotech/pharma company, preferably in biologics
    • Experience with regulatory writing
    • Understanding of the development of advanced therapy/innovative biologics products a plus
    • Knowledgeable in FDA and ICH guidelines
    • Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

Keywords: bluebird bio, Somerville , Manager, Regulatory Strategy, Executive , Somerville, Massachusetts

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