Director, Regulatory Writing

Neurona Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Neurona Therapeutics is seeking a Director of Regulatory Writing to lead the development, authoring, and quality oversight of regulatory documents from early clinical to post-approval activities. You will translate complex science into submission-ready documents for cellular therapy programs.

The ideal candidate has extensive regulatory writing experience for biologics or cell/gene therapies, strong communication, and the ability to manage external vendors and cross-functional teams.

Qualifications

• 8–12+ years of regulatory writing experience with major submissions.
• Experience supporting global regulatory submissions for biologics or cell/gene therapies.
• Experience managing external regulatory writing vendors.
• Strong written and verbal communication in a fast-paced environment.

Responsibilities

• Lead authoring and oversight of regulatory documents across CMC, clinical, and integrated submissions.
• Drive regulatory writing strategy and ensure submission readiness and consistency.
• Prepare FDA/health authority briefing materials and responses to information requests.
• Coordinate with cross-functional teams to maintain timelines and quality.

Skills

Regulatory writing

Scientific writing

Project management

Communication skills

Education

PhD in a relevant scientific discipline

BSc/MSc in a relevant field

Tools

ICH guidelines

CDISC

eCTD structure

Job description

Reports to: Head/SVP, Regulatory Affairs

About the Company

Neurona Therapeutics Inc is a biotechnology company developing innovative regenerative and cellular therapies for patients living with serious neurological diseases where significant unmet medical needs remain. Our lead program is focused on the development of a novel cellular therapy for epilepsy, with additional opportunities in other neurological disorders.

We are advancing transformative therapies designed to address the underlying biology of disease and improve outcomes for patients who have limited therapeutic options. As we progress through late-stage clinical development and toward regulatory submission, we are seeking an experienced regulatory writing leader to join our growing Regulatory Affairs organization.

Position Summary

The Director, Regulatory Writer will provide strategic and hands‑on leadership for the development, authoring, and quality oversight of regulatory documents supporting the Company's cellular therapy programs from early‑stage clinical development through marketing application and post‑approval activities.

This individual will serve as a key scientific and regulatory writer across CMC, clinical, and integrated regulatory submissions, translating complex scientific, manufacturing, clinical, and regulatory information into clear, accurate, compelling, and submission‑ready documents.

The Director will have significant responsibility for leading the preparation of major FDA submissions and interactions, including IND amendments, BLA/NDA/MAA submissions, FDA/ EMA and other health authority meeting briefing packages, responses to information requests, clinical protocols, investigator‑facing documents, and regulatory correspondence.

The ideal candidate combines exceptional scientific and technical writing skills with a strong understanding of cellular therapy/regenerative medicine development, CMC, clinical development, and global regulatory requirements. Experience working with novel cell-based products, combination products, or products involving complex manufacturing and administration technologies is highly desirable.

This is a highly collaborative role requiring the ability to work effectively with Regulatory Affairs, CMC, Clinical Development, Clinical Operations, Biostatistics, Quality, Manufacturing, and senior scientific leadership.

Key Responsibilities

• Serve as a central writing partner to Regulatory Affairs, CMC, Clinical Development, Clinical Operations, Biostatistics, Quality, Manufacturing, Medical Affairs, and senior leadership.
• Work closely with CMC and Clinical teams to ensure that submission content is scientifically rigorous, internally consistent, appropriately referenced, and aligned with regulatory strategy.
• Lead regulatory writing strategy across programs and partner with Regulatory Affairs leadership to ensure consistency across regulatory documents from early planning through final submission.
• Identify scientific, regulatory, and documentation gaps that may affect submission quality, timelines, or regulatory outcomes.
• Establish and maintain regulatory writing standards, templates, processes, and best practices.
• Drive document development timelines and ensure deliverables meet submission milestones and applicable submission standards.
• Resolve conflicting comments and facilitate efficient review cycles while maintaining document consistency and scientific integrity.
• Support document QC and submission readiness activities.
• Lead and oversee authoring and development of major regulatory submissions, including:
• IND / BLA/MAA modules and supporting documents including amendments/supplements
• Clinical study reports, integrated summaries, overviews and summaries (quality, nonclinical, clinical), risk management and benefit-risk documentation
• Regulatory briefing materials and supporting documentation, responses to FDA and other health authority information requests,
• Clinical protocols and amendments, statistical analysis plan-related regulatory content

Required Qualifications

• Advanced scientific degree strongly preferred (PhD in a relevant scientific discipline is highly desirable, including cell or molecular biology, neuroscience, pharmacology, biomedical sciences, or a related field); BSc/MSc degree in a relevant scientific or technical discipline with substantial regulatory writing experience may be considered.
• 8–12+ years of relevant experience in regulatory writing with demonstrated experience authoring or leading major regulatory submissions, including BLA and/or NDA submissions preferably for biologics, or cell and gene therapies.
• Experience supporting global regulatory submissions with a strong understanding of regulatory requirements and expectations for biologics and/or cellular products.
• Exceptional written and verbal communication skills, strong project management skills and ability to operate effectively in a fast‑paced environment.
• Familiarity with ICH guidelines, CDISC/clinical data standards, and electronic Common Technical Document (eCTD) structure.
• Experience managing external regulatory writing consultants or vendors.
• Experience supporting a drug‑device combination product with complex administration technologies and expedited regulatory designation is a plus
• Experience working with therapies for neurological disorders, epilepsy, neurodegenerative disease, or other CNS indications is a plus.