Associate Director/Director, Regulatory Affairs

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Associate Director/Director, Regulatory Affairs

The Company

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

 The Position

This position will report to the Vice President of Regulatory Affairs. As the Associate Director/Director of Regulatory Affairs, you will be responsible for development and implementation of regulatory strategy for assigned projects, serving as the regulatory lead on project teams, and serving as the regulatory contact with regulatory authorities.

Responsibilities:

  • Serve as the regulatory lead on project teams with expertise in U.S. and EU regulatory affairs
  • Develop and implement regulatory strategy for assigned projects in all stages of development (pre-IND/pre-CTA through approval and life-cycle management)
  • Project manage regulatory deliverables coordinating all aspects of regulatory submissions for assigned projects
  • Author regulatory documents in support of filings including INDs/CTAs, Briefing Materials, and BLAs/MAAs
  • Work collaboratively on cross-functional teams taking a problem-solving approach
  • Identify regulatory risks and provide proposals for risk mitigations
  • Prepare and deliver effective presentations for external and internal audiences
  • Lead interactions with regulatory agencies
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Mentor other Regulatory staff members

Qualifications

  • A minimum of a Bachelor’s degree required
  • Advanced scientific degree preferred (i.e. MS, PharmD, PhD, etc.)
  • A minimum of 8 years of pharmaceutical/biotechnology industry experience and 5 years in regulatory affairs
  • Experience working on products in development specifically relating to clinical and nonclinical regulatory aspects of the project
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Knowledge of GCPs and GLPs
  • Excellent communication (written and verbal) and influencing skills
  • Strong organizational skills, including the ability to prioritize workload
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively, Specifically, an ability to provide viable approaches to problem-solving based upon an ability to interpret current Regulations and Guidances for unique applications for innovative gene therapy products

1MS