Regulatory CMC Writer
- United Kingdom
- Contract
- Full-time
- Job type:
CMC * Location:
United KingdomCity of London, EnglandPosting date: 26 Aug 2025Reference: 66621Shape your future with the freedom to work where you thrive! Join our client in this fully remote role that fits your life.Proclinical is seeking a detail-oriented Regulatory Affairs CMC Writer to support the preparation of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions. This role focuses on authoring key sections of regulatory documents, including Module 2.3 (Quality Overall Summary), Module 3 (Quality), and CMC-specific content for Briefing Books used in Scientific Advice procedures with regulatory agencies.Responsibilities:
- Draft and revise Module 2.3 (Quality Overall Summary) to ensure alignment with Module 3 and compliance with ICH guidelines.
- Prepare and update Module 3 (Quality) sections, covering drug substance, drug product, and control strategies based on source data and development reports.
- Author CMC-specific content for Briefing Books submitted to regulatory authorities for Scientific Advice procedures.
- Ensure all documents meet internal standards and regulatory requirements (e.g., EMA, FDA, ICH).
- Collaborate with internal CMC experts, QA, Regulatory Affairs, and external manufacturing partners to gather technical information.
- Align content across modules to maintain scientific consistency and regulatory clarity.
- Support regulatory strategy by providing scientifically sound CMC documentation aligned with the overall development plan.
- Contribute to responses to agency questions or follow-ups related to CMC topics.
- Background in Life Sciences, Chemistry, Pharmacy, or a related field (advanced degree preferred).
- Experience in CMC regulatory writing, including preparation of Modules 2.3, 3, and CMC sections of Briefing Books for EU and/or US regulatory submissions.
- Strong knowledge of ICH guidelines and EMA/FDA CMC requirements, including eCTD submission formats.
- Excellent writing, analytical, and communication skills in English.
- Ability to work independently in a remote or virtual team environment.
- High attention to detail with a focus on document structure and scientific clarity.
- Familiarity with document management systems and collaborative writing tools (e.g., Veeva, SharePoint) is a plus.
- Experience with biologics, cell and gene therapy, or complex injectables is advantageous.
- Prior engagement with regulatory agencies (e.g., EMA, FDA, MHRA) is preferred.