Career Opportunities in the Foresite Capital Network

About Voyager

Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com.

Voyager Therapeutics is seeking a Vice President of Regulatory Affairs to join our growing organization. The Vice President will provide strategic leadership for all regulatory activities and drive the operationalization of product development programs, ensuring the Company's ongoing compliance with regulatory mandates. The VP will, be responsible for devising and implementing regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice, and counseling in all areas of development. The leader will play a key role in fostering strong relationships and advocacy with FDA and other international regulatory authorities, as required.

Responsibilities

• Formulate a comprehensive and compelling strategy and drive the execution of tactical plans to achieve Voyager’s regulatory goals.
• Oversee all regulatory submissions from pre-IND to BLA filings as well as all filing with health authorities on a global basis.
• Provide direct regulatory oversight to all applicable pre-clinical, clinical and CMC activities.
• Develop and design robust regulatory structures, processes, and procedures.
• Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Voyager’s leaders and drive interactions between the Company and regulatory authorities.
• Present and communicate with key internal and external stakeholders regarding regulatory strategy and relevant issues.
• Monitor regulatory landscape and keep colleagues apprised of new or changing regulatory developments and strategic impact.
• Actively participate in company governance committees as required.

Experience

• BS degree focusing on life sciences or related area; an advanced degree e., MS, PharmD, PhD, MD) is preferred.
• Minimum 10 years of progressive experience in Regulatory Affairs strategy within the pharmaceutical industry.
• Demonstrated enterprise leader with a minimum of 5 years functional leadership and people management.
• Experience leading, designing, writing, and submitting regulatory filings with BLA filing experience required. Previous product approval preferred.
• Previous interaction with CBER strongly preferred.
• Global filing experience preferred.
• Experience in neurology and gene therapy areas preferred.
• Ability to provide innovative strategies in complex regulatory landscapes preferred.
• In-depth understanding of drug development and product commercialization preferred.
• Excellent oral and written communications skills with the ability to compellingly influence.
• Demonstrated ability to build cross-functional relationships and work collaboratively is a must.
• Proven sense of urgency in managing project teams to meet goals and deadlines is required.