Remote Senior Director, Regulatory Program Leadership

Neurogene; Houston (TX); Remote; USD 180,000 - 270,000; Full time

Job summary

Neurogene is seeking an experienced Regulatory Affairs professional to lead cross-functional regulatory activities for a gene therapy pipeline. The role focuses on planning, coordinating, and executing regulatory submissions and health authority interactions to support pivotal clinical development and BLA activities.

Sits at the intersection of Regulatory Affairs, CMC, Clinical, Nonclinical, and Quality to ensure on-time delivery of compliant submissions, with remote work options and occasional

Qualifications

• BS/BA degree in life sciences or related field; advanced degree preferred.
• 11+ years in Biotech/Pharmaceuticals with regulatory submissions experience, including BLA; US submissions highly valued.
• Experience with FDA interactions and eCTD submissions; strong project management skills.

Responsibilities

• Serve as regulatory project management lead on cross-functional program teams, representing 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.
• Coordinate authoring, review, QC, and approval cycles across CMC, Clinical, Nonclinical, and Biostatistics.
• 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 to ensure progress toward deadlines.
• Contribute to the development and continuous improvement of regulatory processes, templates, SOPs, and best practices.

Skills

Regulatory project management

Cross-functional collaboration

Regulatory strategy

Time management

Education

BS/BA in life sciences

MS/PhD in life sciences

Tools

Veeva Vault RIM

MS Project

Smartsheet

eCTD submission knowledge

Job description

Neurogene is seeking an experienced Regulatory Affairs professional to lead cross-functional regulatory activities for a gene therapy pipeline. The role focuses on planning, coordinating, and executing regulatory submissions and health authority interactions to support pivotal clinical development and BLA activities.

Sits at the intersection of Regulatory Affairs, CMC, Clinical, Nonclinical, and Quality to ensure on-time delivery of compliant submissions, with remote work options and occasional