Director, Regulatory Writing – Cell Therapy

Neurona Therapeutics; United States; Hybrid; USD 180,000 - 280,000; Full time

Job summary

Neurona Therapeutics is seeking a Director, Regulatory Writer to lead the development and quality oversight of regulatory documents supporting cellular therapy programs from early development to post-approval.

The role combines strategic leadership with hands-on authoring across CMC, clinical, and global regulatory submissions, including IND, BLA/NDA, and regulatory briefing materials, ensuring clarity, compliance, and submission readiness.

Qualifications

• Advanced scientific degree preferred; PhD highly desirable.
• 8–12+ years of regulatory writing experience, incl. major submissions (BLA/NDA).
• Experience with global regulatory submissions for biologics or cell/gene therapies.
• Excellent written/verbal communication and strong project management.

Responsibilities

• Serve as central writing partner to Regulatory Affairs, CMC, Clinical Development, Clinical Operations, Biostatistics, Quality, Manufacturing, Medical Affairs, and leadership.
• Ensure submission content is scientifically rigorous, internally consistent, and aligned with regulatory strategy.
• Lead regulatory writing strategy across programs and partner with Regulatory Affairs leadership for consistency in documents.
• Identify scientific, regulatory, and documentation gaps that may affect submission quality or timelines.
• Establish and maintain regulatory writing standards, templates, processes, and best practices.
• Drive document development timelines and ensure deliverables meet submission milestones.
• Resolve conflicting comments and facilitate efficient review cycles while maintaining document integrity.
• Support document QC and submission readiness activities.
• Lead and oversee authoring of major regulatory submissions, including IND / BLA/MAA modules and related documents.
• Clinical trial application / global IMPD preparation, Investigator’s brochure
• Clinical study reports, integrated summaries, overviews and summaries (quality, nonclinical, clinical)
• Regulatory briefing materials and responses to FDA and other Health Authority information requests
• Clinical protocols and amendments, statistical analysis plan‑related regulatory content

Skills

Regulatory writing

Leadership

Regulatory strategy

Project management

Communication

Cross-functional collaboration

Education

PhD in a relevant scientific discipline

BSc/MSc with regulatory writing experience

Job description

Neurona Therapeutics is seeking a Director, Regulatory Writer to lead the development and quality oversight of regulatory documents supporting cellular therapy programs from early development to post-approval.

The role combines strategic leadership with hands-on authoring across CMC, clinical, and global regulatory submissions, including IND, BLA/NDA, and regulatory briefing materials, ensuring clarity, compliance, and submission readiness.