Senior Director, Global Regulatory Lead

Our 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.

Senior Director, Global Regulatory Lead

The Senior Director, Global Regulatory Lead will be responsible for developing and delivering innovative global regulatory strategies for product development and approval. The individual will provide strategic direction and guidance on regulatory requirements for assigned gene therapy development programs, driving premarket strategies that lead to robust submissions and timely product approvals.

Regulatory Affairs
May 18 2021
Key Responsibilities
  • Drive global regulatory affairs strategies and activities across assigned programs.
  • Partner closely with cross-functional colleagues to articulate and translate nonclinical and clinical regulatory requirements into practical, strategic regulatory strategies and plans.
  • Identify and assess regulatory risks & define strategies to mitigate such risks
  • Plan, write, and review drug applications and submissions, as well as represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
  • Prepare for and support meetings with regulatory bodies
  • Build and maintain excellent relationships with relevant regulatory agencies
  • Monitor impact of changing regulations on submission strategies
  • Serve as regulatory subject matter expert throughout product lifecycle
Minimum Requirements/ Qualifications
  • 15+ years pharmaceutical/biotechnology industry experience in Regulatory Affairs
  • University degree required; advanced degree(s) preferred
  • Experience with rare disease therapeutic products, and experience with cell and gene therapy products highly desirable
  • Experience as lead regulatory representative for development programs required, with sufficient gravitas to lead develop team through regulatory processes
  • Experience and comfort with a fast-paced small biotech company environment
  • Knowledge and experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs
  • Demonstrate excellent leadership and communication skills
  • Demonstrate strong organizational and interpersonal skills

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 Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical 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, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer