Regulatory Toxicologist R&d

hace 2 semanas


Vall de Bianya, España Zoetis A tiempo completo

Toxicological Assessment support: Safety assessments for formulation excipients, degradant materials, ingredients, and residual solvents in drug substances and drug products
- Toxicological Assessment supporting manufacturing: Qualifying impurities in the manufacturing process for drug substances and drug products; safety assessments for extractable and leachable; cross-over contamination of products at shared facilities and cleaning limits.
- Perform rigorous toxicology gap analysis, data mining, and systematic literature review.
- Toxicological evaluation and establishment of a hazard and health
- based exposure limits such as Permitted Daily Exposure (PDE), Margin of exposure (MoE) etc.
- Health hazard/ Medical assessments: supporting pharmacovigilance, product quality, and out-of-specification batches.
- User/handler safety support: Safety support for project teams (writes the documents, assembles various scenario calculations and risk mitigation proposals, packaging choice, label language)
- Regulatory filing support: Integration of toxicology, human food safety, target animal safety, and user safety assessments into filing documents
- Response to global regulatory queries


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    Encontrado en: beBee jobs ES - hace 1 semana


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    Encontrado en: beBee jobs ES - hace 6 días


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    Encontrado en: beBee S ES - hace 3 semanas


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