Senior Director, Program Management, Regulatory Affairs

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile.

The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission.

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

Remote, with some travel for regulatory meetings

Reports To (Position): VP, Regulatory Affairs

We are a pioneering company developing a gene therapy for rare pediatric neurodegenerative disease. We have a program in registrational studies and have just kicked off their BLA process,. We need a skilled Regulatory professional to drive the planning, coordination, and execution of regulatory activities supporting our gene therapy pipeline. Sitting at the intersection of Regulatory Affairs, CMC, Clinical, Nonclinical, and Quality, this role ensures that regulatory submissions and health authority interactions are delivered on time, to a high standard, and in alignment with program strategy.

Accountabilities and Responsibilities

• Serve as the regulatory project management lead on cross-functional program teams, representing regulatory timelines, dependencies, and risks.

• Lead regulatory sub-team meetings, prepare agendas, capture decisions and action items, and drive accountability.

• Develop and maintain integrated submission timelines, content plans, and responsibility matrices in partnership with Regulatory Leads and functional authors.

• Drive document readiness by coordinating authoring, review, QC, and approval cycles across CMC, Clinical, Nonclinical, and Biostatistics.

• Lead regulatory sub-team meetings, prepare agendas, capture decisions and action items, and drive accountability

• Manage regulatory information and FDA interactions through review, maintaining the document management system and submission archive

• Set milestones and timelines, and implement tracking dashboards, databases, and project management tools (e.g., Smartsheet, Veeva RIM) to ensure efficient progress towards Company goals and meet critical target dates

• Contribute to the development and continuous improvement of regulatory processes, templates, SOPs, and best practices

Minimum Requirements

Education:

• BS/BA degree in life sciences or related field

AND

11+ years of experience in Biotech/Pharmaceutical industry, including drug development experience with demonstrated success in regulatory authority submission strategy, execution and health authority interaction. Prior US marketing application filing experience preferred; Ex-US experience strongly preferred. Experience in writing and leading regulatory documents (e.g., meeting requests/briefing book activities).

OR

• Master's degree in life sciences or related field AND 9+ years of related experience

OR

• PhD in life sciences or related field AND 6+ years of related experience

Experience

• Substantial experience with regulatory affairs program management and oversight of complex regulatory submissions including BLA submission experience in Rare Disease and/or Gene Therapy is strongly preferred (both would be ideal)

• Pediatric submissions experience nice to have

• Direct experience supporting regulatory submissions for biologics, cell therapies, or gene therapies.

• Working knowledge of FDA and EMA regulations, ICH guidelines, and the eCTD submission format.

• Demonstrated ability to manage multiple concurrent projects with competing

deadlines in a fast-paced environment.

• Proficiency with project management tools (e.g., MS Project, Smartsheet) and regulatory information or document management systems (e.g., Veeva Vault RIM)

Licenses or Certifications

• RAPS certification preferred, but not required

Knowledge, Skills & Attributes

• Attention to detail for preparing accurate documentation and maintaining regulatory compliance

• Proven ability of problem-solving skills to navigate regulatory changes or project constraints

• Excellent time management skills enable handling multiple projects at the same time, balancing priorities and ensuring timely completion

• 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.

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.