Regulatory Affairs Manager – Gene Therapy (Remote)

Neurogene Inc.; New York (NY); Hybride; USD 150 000 - 190 000; Plein temps

Résumé du poste

Neurogene Inc. in New York City or remote is seeking a Manager, Regulatory Affairs to lead regulatory strategies and high‑quality submissions for late‑stage programs. You will collaborate across functions, ensuring alignment with global regulatory expectations and timelines.

The role requires deep knowledge of GxP, FDA/ICH guidelines, and strong communication to drive efficient filings and program advancement in a fast‑paced gene therapy environment.

Qualifications

• BS, MS or PhD in a scientific discipline.
• 5-7 years with Bachelor's, OR 4-6 with Master's, OR 3-5 with Ph.D. in biotech, with at least 3 years in Regulatory Affairs.
• Experience with biologic and/or gene therapy products preferred.

Responsabilités

• Develop and implement regulatory strategies for therapeutic programs from candidate selection through post-marketing
• Provide regulatory representation to cross-functional project teams and guidance on submission requirements
• Review clinical study documentation, protocols, informed consent documents, and recruitment materials
• Coordinate authoring, editing, submission, and archival of regulatory documents (INDs/CTAs, BLAs/MAAs, etc.)
• Develop and manage timelines for regulatory submissions
• Maintain knowledge of FDA and international regulations and pipeline impact
• Engage with regulatory authorities to advance product development and keep programs in good standing
• Support gene therapy-specific requirements including long-term follow-up commitments and pharmacovigilance

Connaissances

GxP knowledge

Regulatory strategy

Communication

Cross-functional collaboration

Project management

FDA/ICH guidelines

Formation

BS/MS/PhD in scientific discipline

Outils

Veeva Vault RIM

Microsoft Office

Adobe Acrobat

Description du poste

Neurogene Inc. in New York City or remote is seeking a Manager, Regulatory Affairs to lead regulatory strategies and high‑quality submissions for late‑stage programs. You will collaborate across functions, ensuring alignment with global regulatory expectations and timelines.

The role requires deep knowledge of GxP, FDA/ICH guidelines, and strong communication to drive efficient filings and program advancement in a fast‑paced gene therapy environment.