Senior Technical Writer

3 weeks ago


Nationwide, United Kingdom RBW Consulting Full time

We are seeking a highly skilled Regulatory Science and Analytical Development Expert to join our dynamic Regulatory Department. In this role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

Responsibilities:
  • Prepare 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 to gather necessary information.
  • Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
  • Manage CMC regulatory submission workflows within the document management system.
  • Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.
  • Communicate project timelines and deliverables to team members and stakeholders.

This is a freelance position until March 2025, although it is likely to be renewed. The salary for this role is estimated to be around $120,000 per year, depending on experience.


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