Description
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.
Requirements
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.
