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Regulatory Toxicologist
* North Yorkshire - with potential hybrid/onsite working depending on project needs
* Up to £50,000 per annum plus benefits
My client is a growing, science-driven Contract Research / Development lab based in Yorkshire, working with clients to support preclinical toxicology, safety assessment and regulatory submissions.
Key Responsibilities
* Review, evaluate and interpret toxicology data (in vitro, in vivo, literature) for preclinical safety assessments.
* Design, oversee or coordinate toxicology and safety-pharmacology studies (outsourced or in-house) in compliance with regulatory and GLP/GCP standards.
* Prepare and compile toxicology / safety sections for regulatory dossiers (e.g. IND / CTA / IMPD / CTD / briefing documents), including hazard / risk assessments, weight-of-evidence reports, and data gap analyses.
* Liaise with external CROs, clients, internal project teams (R&D, regulatory affairs, project management) to coordinate study plans, timelines and deliverables.
* Provide scientific advice on testing strategy, toxicological risk, and regulatory compliance throughout non-clinical development.
* Maintain up-to-date knowledge of regulatory guidelines and scientific developments; ensure compliance with relevant frameworks.
* Peer-review work, supervise or mentor junior scientists / toxicologists, and contribute to project- and lab-level safety strategy.
* Communicate findings internally and to external stakeholders / clients; produce clear, high-quality reports and regulatory-ready documents.
The Regulatory Toxicologist will have:
* MSc / PhD (or equivalent) in Toxicology, Pharmacology, Biomedical Sciences, Biochemistry, or related life-science discipline.
* Solid experience in toxicology, safety pharmacology or non-clinical safety assessment — ideally within a pharmaceutical, biotech or CRO environment.
* Familiarity with in vitro and/or in vivo toxicology methods, ADME/TK, genotoxicity, safety pharmacology or related toxicity endpoints.
* Strong understanding of regulatory requirements, guidelines (e.g. ICH, GLP), and dossier preparation processes.
* Excellent scientific writing and communication skills; ability to produce regulatory-quality reports.
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