M Pharma Regulatory toxicologist @ Syngene – Apply Online
Syngene is hiring for a Regulatory toxicologist. Candidates with an MSc degree in chemical science may apply for the job opening. M Pharna job opening 2023, Pharmacy job opening 2023, Pharma job. Interested and eligible candidates may check out all the details
Job Title: Regulatory toxicologist
Job Location: Bengaluru
Job Grade: 8-II
Eligbility Criteria MSc/MPharm/MVSc
Experience 1-3 Years
Skills and Capabilities
• Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/API/ Pharmaceuticals used in consumer and OTC products.
• Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
• Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals.
• Conduct risk assessment for raw materials for cosmetic applications including Margin of safety calculations
• To derive Health Based exposure limit (PDE/OEL/DNEL/ADI) for Pharmaceuticals/ cosmetics/ nutraceuticals/ agrochemicals/ botanicals
• To provide evidence of efficacy and safety (preclinical and clinical) as per regulatory requirements
• Preparation of Safety Data sheet in compliance with GHS
• Scientific literature search -To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc.
• To evaluate quality of different toxicity studies (such
as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reprotoxicity and developmental, toxicokinetics studies) as per OECD/ ICH /FDA/ISO guidelines• To prepare research reports/ dossiers according to the international regulatory guidelines
Apply Online
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