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Assoc. Director / Director, Global Regulatory Affairs

Company: AVROBIO
Location: Portland
Posted on: May 27, 2023

Job Description:

Assoc. Director / Director, Global Regulatory AffairsOur culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.The Associate Director or Director, Regulatory Affairs integrates and applies knowledge of US, EU and global regulatory guidelines to AVROBIO's pipeline development programs. Ensures global strategies are developed and successfully implemented and executed across AVROBIO's portfolios, interfaces cross-functionally both within AVROBIO and external service providers/partners, participates as a member of the project program development team(s) to build awareness of Regulatory Authority requirements and timing for submissions, demonstrates leadership and has comprehensive understanding of global regulations and guidelines to address and overcome challenges that arise during development and commercialization. The Associate Director/Director will collaborate with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA and global Health Authorities and successfully communicate and negotiate directly and indirectly with international Health Authorities as necessary. Remote Regulatory Affairs May 8 2023 Key Responsibilities

  • Develop and implement global regulatory strategies including timings for regulatory interactions, pediatric development, orphan drug designations and routes to approval
  • Highlight and mitigate potential risks to timelines and deliverables
  • Lead regulatory submission activities and author/review regulatory documents prior to submission to ensure overall quality, compliance and timeliness
  • Coordinate cross-functional teams in the R&D organization to review and approve submission document deliverables and ensures quality is maintained
  • Collect and analyze regulatory intelligence for assigned projects and communicate assessments with advice on regulatory significance and options.
  • Lead document and meeting preparation for global regulatory authority interactions and negotiations as needed for all aspects pertaining to drug development Minimum Requirements/ Qualifications
    • BS degree in a science related field and a minimum of 6+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry in positions of increasing strategic and leadership scope; advanced degree preferred (PhD, MS, PharmD, or equivalent)
    • Experience in the development and preparation of successful regulatory strategies
    • Experience interacting with the FDA and ex-US health authorities and current knowledge of global regulations, and guidance's/guidelines
    • Cell and gene therapy and/or rare disease experience preferred
    • Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
    • Individual contributor with the ability to work in a fast-paced, start-up environment; excellent interpersonal skills including verbal and written communication are essential in this collaborative work environmentOur vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Gaucher disease type 1 and cystinosis, as well as programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato - gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Massachusetts.

Keywords: AVROBIO, Portland , Assoc. Director / Director, Global Regulatory Affairs, Executive , Portland, Oregon

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