About Voyager Therapeutics

Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.

Job Summary

The Director, Regulatory CMC will provide regulatory CMC leadership for program teams developing biologic and cell and gene therapy products. This position is responsible for driving global CMC RA strategy and execution, including the generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in collaboration with stakeholders. This position will partner with SMEs across the organization to author and review key regulatory documents, represent the organization at health authority meetings, and help shape the regulatory organization.

Position Specific Responsibilities:

• Oversees, recommends and implements CMC regulatory strategy activities in alignment with company goals.
• Ensure cross-functional alignment and effective communication of regulatory CMC requirements and strategies.
• Provides expertise on CMC regulatory matters by interpreting global regulations and guidance and identifying opportunities and risks.
• Manages preparation, review, and submission of high-quality regulatory documents, that are accurate and compliant with global regulatory requirements to support development programs in close partnership with internal stakeholders and external partners. This includes IND, IMPD, CTA, briefing documents, responses to questions, and marketing applications.
• Leads regulatory CMC discussions with global regulatory authorities.
• Reviews and provides regulatory assessments on change controls.
• Works closely with subject matter experts within CMC operations, R&D and QA to strengthen internal capabilities.
• Builds/maintains relationships cross-functionally to ensure efficient implementation of regulatory activities.
• Contributes to improvements in department best practices and SOPs.
• Monitors and interprets evolving global regulatory CMC requirements and communicates potential impact to internal stakeholders.

Specialized Knowledge & Skills:

• Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.
• Experience in development, manufacturing and testing of cell therapy, gene therapy products or mRNA-based therapeutics is highly desired.
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
• Experience in supporting the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.

Requirements:

Educational Requirements:

• Bachelor of Science in a scientific discipline with 10+ years relevant pharmaceutical experience or advanced degree (MS/PharmD/PhD) with 8+ years of relevant experience.

Experience:

• At least 5 years prior experience in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics cell therapy, gene therapy or mRNA-based therapeutics; with deep experience in product development and understanding of US, international regulations, and ICH guidelines related to CMC development. Device experience is desirable, but not required.