Assoc. Director / Director, Global Regulatory Affairs

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 environment

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About AVROBIO

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