Director, Regulatory Affairs CMC

Company Background

At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders.  Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Position Overview - New York, Houston or Remote

We are seeking a Director, Regulatory Affairs CMC, to join the Regulatory Affairs CMC team to support a novel rare disease CNS pipeline. The individual will be part of a team that will provide support to the Regulatory Affairs (CMC) Team and the CMC/Manufacturing Teams at our gene therapy manufacturing facility in Houston to develop, plan, and execute the regulatory strategy to facilitate the achievement of the company’s short and long-term objectives. This individual will be a team player with roll-up-sleeve approach, can-do attitude and functional subject matter expertise in CMC. This role will be an integral part of the transformative shift the company is making from the clinical development stage to commercialization.