Director, Regulatory Writing - Remote (Cellular Therapy)

Neurona Therapeutics; South San Francisco (CA); Hybrid; USD 170,000 - 230,000; Full time

Job summary

Neurona Therapeutics is seeking a Director of Regulatory Writing to lead the development, authoring, and quality oversight of regulatory documents for cellular therapy programs from early development through post‑approval. You will translate complex scientific data into submission‑ready documents across CMC, clinical, and regulatory sections.

The role requires leading major regulatory submissions (IND, BLA/MAA), coordinating with global health authorities, and mentoring teams to ensure rigorous,

Qualifications

• Advanced scientific degree strongly preferred (PhD).
• 8–12+ years in regulatory writing with major submissions experience.
• Global regulatory submissions understanding for biologics/cellular products.
• Exceptional written/verbal communication and project management skills.

Responsibilities

• Serve as central writing partner to Regulatory Affairs, CMC, Clinical Development, Clinical Operations, Biostatistics, Quality, Manufacturing, Medical Affairs, and senior leadership.
• Lead regulatory writing strategy and ensure content aligns with regulatory strategy.
• Identify gaps that affect submission quality, timelines or outcomes.
• Establish and maintain regulatory writing standards, templates and best practices.
• Drive document development timelines to meet submission milestones.
• Oversee authoring of major regulatory submissions (IND/BLA/MAA) and related documents.
• Support document QC and submission readiness activities.
• Prepare clinical study reports, integrated summaries, and briefing materials.

Skills

Regulatory writing leadership

FDA/submissions

Scientific writing

Project management

ICH guidelines

Education

PhD in relevant scientific field

BSc/MSc with regulatory writing experience

Job description

Neurona Therapeutics is seeking a Director of Regulatory Writing to lead the development, authoring, and quality oversight of regulatory documents for cellular therapy programs from early development through post‑approval. You will translate complex scientific data into submission‑ready documents across CMC, clinical, and regulatory sections.

The role requires leading major regulatory submissions (IND, BLA/MAA), coordinating with global health authorities, and mentoring teams to ensure rigorous,