Director, Regulatory – CMC, Gene Therapy

Cambridge, MA
Posted 3 months ago

Director, Regulatory – CMC, Gene Therapy

Ensure global strategies are successfully implemented and executed across our portfolios. Interface cross-functionally with internal teams and external service providers/partners. Demonstrate leadership and comprehensive understanding of global RA CMC regulations and guidelines to address and overcome challenges that arise during development and commercialization. Successfully communicate and negotiate directly and indirectly with international Health Authorities as necessary.

Key Responsibilities:

  • Develop and implement global CMC regulatory strategies for clinical and early development stage gene therapy projects.
  • Lead CMC regulatory activities and timelines. Manage and implement planning, preparation and submission of high-quality CMC related applications.
  • Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; lead the preparation and submission of responses to CMC questions; supports interactions with regulatory agencies during GMP and pre-approval inspections.
  • Manage and ensure compliance with all reporting requirements.
  • Provide CMC regulatory guidance for global development programs.
  • Provide regulatory CMC support for clinic development activities. Provide advice and carefully considered decisions regarding regulatory issues for which there may not be clear/specific regulatory guidance or precedence.

Minimum Requirements/Qualifications:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree (PhD) preferred.
  • 8 + years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience.
  • Demonstrated hands-on experience in clinical and/or commercial stage gene therapy products.
  • Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global gene therapy development and post-approval support.
  • Demonstrated experience in preparing IND and/or NDA submissions.
  • Proven ability to deal with issues of critical importance.
  • Demonstrated leadership, problem-solving ability, flexibility and teamwork.
  • Demonstrated ability to work well within a matrix structure in a scientifically complex environment.
  • Exercises good judgment in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
  • Excellent written and oral communication skills are required.

Other Requirements:

  • Travel requirements – 5-10%

To apply, email your resume to:
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

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