Assoc. Director / Director, Global Regulatory Affairs

• Lead document and meeting preparation for global regulatory authority interactions and negotiations as needed for all aspects pertaining to drug development
• 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
• 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 regulatory submission activities and author/review regulatory documents prior to submission to ensure overall quality, compliance and timeliness

• 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 interacting with the FDA and ex-US health authorities and current knowledge of global regulations, and guidance’s/guidelines
• 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 environment
• Cell and gene therapy and/or rare disease experience preferred
• Experience in the development and preparation of successful regulatory strategies
• Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines

Our 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.

AVROBIO, Inc is an EEO employer