Regulatory Toxicologist R&D

col-wideJob Description: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