Senior Director, CMC Regulatory Affairs

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.

The Senior Director, CMC Regulatory Affairs plays a critical role in the development and execution of an integrated global regulatory strategy for successful gene therapy development. In partnership with functional areas leads and regulatory subject matter experts, the Sr. Director is responsible for the oversight, development and execution of global CMC regulatory strategies for AVROBIO’s regulatory submissions from INDs/CTAs, briefing books to license applications and will ensure regulatory compliance is maintained.

Regulatory Affairs
May 8 2023
Key Responsibilities
  • Provide leadership and guide the overall CMC regulatory strategy for all programs from early development through to marketing applications and post marketing activities
  • Influence strategy to address internal or external business and regulatory issues and proactively identify potential strategic issues and opportunities
  • Develop submission plans and timelines for CMC in partnership with all other Regulatory subject matter experts for coordination
  • Drive and execute the CMC regulatory activities that lead to successful IND/CTA and global marketing applications
  • Identify, assess, and communicate potential risks associated with development and regulatory strategy scenarios and plan risk mitigation strategies
  • Interact directly with global regulatory agencies and ensure that interactions are properly communicated to the CMC teams and/or business partners. Triage, coordinate and manage responses to questions from regulatory authorities by collaborating with the CMC teams to address regulatory agency feedback and define long and short-ranged actions
  • Responsible for the coordination, timely preparation, review and submission of CMC documentation packages for regulatory agency interactions
  • Direct or manage resources of the authoring and preparation of CMC sections as applicable
  • Review product development and technical documentation for regulatory compliance and inclusion in submissions global regulatory agencies
  • Work collaboratively on cross functional teams, including process development, manufacturing, supply chain, quality, and regulatory to manage activities and/or changes related to product development, manufacturing, and commercialization
  • Manage external regulatory consultants and project deadlines
  • Ensure compliance with company standards and the applicable regulations
  • Review product labeling for clinical trial and commercial labeling
Minimum Requirements/ Qualifications
  • BA/BS degree required, MS preferred, in an appropriate scientific field with 15+ plus years direct professional experience in CMC development in biopharmaceuticals; strong understanding of cell and gene therapy drug development and regulatory approval process
  • Detail-oriented, organized, with ability to influence others and a customer-focused mindset
  • Strong understanding of biotech/cell & gene therapy regulations essential (ICH and other governing documents, US and Global), rare disease experience preferred
  • Comfortable in agile environments; capable of bringing structure to vaguely defined problems while using creative yet pragmatic problem-solving approaches
  • Highly effective written and verbal communication skills; strong presentation, facilitation, and stakeholder management skills
  • Demonstrated experience in CMC development and implementation of business processes that enhance organizational sustainability
  • Demonstrated ability to coach team leaders in navigating the complexities of a cross-functional, matrixed organization that is dynamic and rapidly evolving
  • Inclusive interpersonal skills; ability to build relationships, influence, and drive organizational change

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