Quality Assurance Technical Writer

4 days ago


London, Greater London, United Kingdom RBW Consulting Full time
About the Role: RBW Consulting is seeking a Quality Assurance Technical Writer - CMC to join our team. As a Quality Assurance Technical Writer - CMC, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

Key Responsibilities:
- Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
- Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
- Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.

Requirements:
- Degree in Pharmacy, Chemistry, Biology, or a related field.
- Previous experience as a scientist in analytical development CMC.
- At least 5 years of technical writing experience in CMC regulatory submissions.

Salary: $90,000 - $110,000 per year, depending on location and experience.

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