Apr 04, 2026
Regulatory CMC Technical Writer
Fully Remote (UK/Europe) | Freelance Contract – Outside IR35 | Occasional International Travel
About the Role
We are seeking an experienced Regulatory CMC Technical Writer to support our client’s global regulatory and pharmaceutical development programmes. This is a fully remote, freelance position operating outside IR35, offering flexibility, autonomy, and the opportunity to collaborate with international teams across the life sciences sector.
The ideal candidate will bring proven expertise in CMC documentation, regulatory submissions, and technical writing within pharmaceuticals, biologics, or advanced therapies.
Key Responsibilities
* Prepare, write, and review high‑quality CMC documentation for global regulatory submissions (e.g., Module 3, IMPD, IND, BLA, CTA).
* Translate complex scientific, manufacturing, and quality information into clear, compliant regulatory content.
* Ensure all documentation aligns with FDA, EMA, MHRA and...
| IR35 Status: |
Outside IR35
|
CV-Library
London, UK
Contractor