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Job Description

This role supports the Pre-Clinical GPRD team by providing scientific expertise and contributing to the execution of nonclinical safety assessment activities. The successful candidate will possess a solid foundation in toxicology and pharmacology,



a working knowledge of current pharmaceutical regulatory requirements (including ICH, ISO, and FDA guidelines), and excellent written and verbal communication skills. Experience in human health hazard evaluation and the practical application of toxicological principles will be considered an advantage.
Key Responsibilities:
- Provide support to senior team members in data management, integration, and related scientific activities.
- Conduct literature reviews, analyze data, and develop compound-specific health hazard profiles.
- Prepare toxicological risk assessments (TRAs) for extractables, leachables, residual solvents, elemental impurities, degradation products, and related substances in accordance with regulatory requirements (FDA, ICH, ISO).
- Design, plan, and monitor in vitro and in vivo toxicology studies conducted at external Contract Research Organizations (CROs).
- Contribute to safety and risk assessments, including impurity qualificat

📌 Research Associate, R&D Pre-Clinical Toxicology (Ahmedabad)
🏢 Baxter International
📍 Ahmedabad