Director of Regulatory Writing - Cell Therapy

Neurona Therapeutics; EE. UU.; Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory writing

Scientific writing

Project management

Communication skills

Educación

PhD in a relevant scientific discipline

BSc/MSc in a relevant field

Herramientas

ICH guidelines

CDISC

eCTD structure

Descripción del empleo

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.