Regulatory Writer
OR
Last updated on 03 Dec 2025
Overview
A Regulatory Writer creates clear, accurate, and compliant documents required for product approvals by health authorities. They translate complex scientific and clinical data into well-structured dossiers, reports, and summaries for regulatory submissions.

Job Description
- Draft, review, and format regulatory documents such as clinical study reports (CSRs), Investigator’s Brochures (IBs), and Common Technical Documents (CTDs).
- Collaborate with cross-functional teams including clinical, safety, and regulatory affairs to gather data.
- Ensure consistency, accuracy, and compliance with global regulatory guidelines (ICH, EMA, FDA).
- Translate scientific findings into submission-ready documents for drug or device approval.
- Revise documents based on internal feedback and regulatory authority comments.
- Maintain templates, document version control, and support audits or inspections when needed.

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