Neurogene Inc. · 1 month ago
Director, CMC, Regulatory Affairs
New York, NY
Full-time
Onsite
Director/Executive
10+ years expNeurogene Inc. is focused on bringing life-changing genetic medicines to patients affected by rare neurological diseases. They are seeking a Director, CMC Regulatory Affairs, to support their gene therapy manufacturing facility in Houston, contributing to the regulatory strategy and ensuring compliance with global requirements.
Biotechnology
Responsibilities
Provide CMC regulatory input to cross-functional teams, including Technical Operations, Process Development, Quality, and Clinical Development
Contribute to global regulatory development plans and participate in CMC strategy discussions at project governance meetings
Partner with Process Development, Analytical Development, Quality, and Manufacturing teams to align regulatory strategies with technical and operational objectives in compliance with all applicable regulations and guidance
Anticipate and proactively identify regulatory risks, supporting mitigation strategies and recommendations
Support cross-functional problem-solving and contribute to decision-making on complex regulatory and CMC development challenges
Ensure compliance with applicable laws, regulations, and guidelines by monitoring and interpreting the regulatory landscape, evolving guidance, and external trends relevant to gene therapy
Lead preparation, review, and submission of CMC components of INDs, CTAs, BLAs, MAAs, and related amendments/supplements for gene therapy products in accordance with global regulatory requirements
Support responses to health authority questions, preparation of briefing packages, and interactions with regulators on CMC matters, including preparation of internal teams for these engagements
Collaborate with clinical regulatory colleagues to ensure cohesive and compliant submissions across all modules
Support the development and maintenance of Regulatory Affairs programs, policies, and procedures
Qualification
Required
Bachelor's degree in life sciences or a related field required
10+ years of experience in Regulatory Affairs CMC with at least 5 years focused on gene therapy, viral vectors, or biologics
Proven success in developing and executing global regulatory CMC strategies for advanced therapy medicinal products (ATMPs) or biologics
Strong track record of leading CMC submissions (IND/CTA through BLA/MAA) for gene therapy or biologics
In-depth understanding of biologics manufacturing, characterization, control strategies, and analytical development
Experience interacting directly with global health authorities
Prior leadership experience managing teams or cross-functional project workstreams
Expert knowledge of global CMC and gene therapy-specific regulations and guidance (FDA CBER, EMA ATMP, ICH Q-series)
Strong scientific understanding of viral vectors (AAV, lentivirus, etc.), manufacturing technologies, and quality control principles
Extensive experience with applicable regulatory requirements, including GXPs, and previous interactions with FDA, EMA, and other regulatory agencies
Exceptional interpersonal and communication skills, with the ability to interact effectively with senior leaders, cross-functional teams, and colleagues at all levels while exercising sound regulatory judgment in complex situations
Strong project management, organizational, and leadership abilities, with the capacity to prioritize and drive initiatives efficiently in a fast-paced environment
Self-starter with high energy, initiative, and motivation, able to instill a sense of urgency and pace within the team
Demonstrated ability to work decisively and collaboratively in a rapidly evolving, high-growth environment
Passionate, creative, and collaborative, with a willingness to take prudent risks and contribute to a mission-driven company focused on transformative treatments for patients
Excellent written and verbal communication skills
Travel to Houston will be required
Preferred
Advanced degree (Ph.D., M.S., or equivalent) in Molecular Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline
Company
Neurogene Inc.
Neurogene is accelerating development of new genetic medicines to people with devastating neurological diseases and their families.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$383.5MKey Investors
EcoR1 Capital
2024-11-04Post Ipo Equity· $200M
2020-12-16Series B· $115M
2019-02-12Series A· $68.5M
Leadership Team
Rachel McMinn
Founder & CEO
Julie Choi Jordan
Chief Medical Officer
Recent News
2025-11-15
2025-11-14
MarketScreener
2025-11-14
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