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 ICH guidelines.
* Work closely with SMEs across Quality, Manufacturing, Analytical Development, Regulatory Affairs, and external partners.
* Maintain document consistency, accuracy, and alignment across multiple projects and versions.
* Contribute to gap analyses, data organisation, and dossier readiness activities.
* Participate in virtual meetings and occasional international on‑site visits as needed.
Experience & Skills Required
* Demonstrable experience as a CMC Technical Writer or Regulatory Medical Writer within pharmaceuticals or biotech.
* Strong understanding of CMC regulatory frameworks, quality systems, and manufacturing processes.
* Prior experience supporting IND/IMPD/BLA/MAA submissions highly desirable.
* Excellent written communication skills with the ability to simplify scientific content.
* Ability to work independently, manage multiple deadlines, and collaborate with global project teams.
* Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology or related field.
Contract Details
* Freelance / Outside IR35
* Contract until September 2026 and extendable
* Fully remote, with flexibility on working hours
* Occasional international travel (project‑dependent)
* Competitive day rate based on experience
How to Apply
If you are a detail‑driven Regulatory CMC specialist who thrives in a flexible freelance environment, we would love to hear from you.
Please submit your CV today