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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.
Key Skills and Requirements:
* 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.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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