CMC Regulatory Writing Expert

3 days ago


London, Greater London, United Kingdom RBW Consulting Full time
Job Description

This Senior CMC Regulatory Document Specialist role is responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

Responsibilities
  • Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
  • Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
  • Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
Requirements
  • Degree in Pharmacy, Chemistry, Biology, or a related field.
  • At least 5 years of technical writing experience in CMC regulatory submissions.
  • In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
  • Exceptional technical writing skills with the ability to clearly communicate complex scientific information.
Salary and Benefits
  • Competitive salary range: €65,000 - €85,000 per annum.
  • Fully remote role with occasional travel to the R&D Centre in Paris, France.
  • Opportunity to work on exciting projects and contribute to the development of groundbreaking therapies.


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