Description

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.

Requirements

Accountability and 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.

Minimum Requirements

Education
• Bachelor's degree in life sciences or a related field required
• Advanced degree (Ph.D., M.S., or equivalent) in Molecular Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline preferred

Experience
• 10+ years of experience in Regulatory Affairs CMC

• 5 years focused on gene therapy, viral vectors, or biologics

• BLA experience required
• 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

Knowledge and Skills
• 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.
• Excellent written and verbal communication skills.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Travel
• Travel to Houston will be required

This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene's business, this description is subject to change and may be modified at any time, whether formally or informally.