Regulatory Toxicologist R&d

hace 9 meses


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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    About us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, industrial area...

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