Syngene looking for Regulatory Toxicologist | M.Pharm, M.Sc apply
Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Regulatory Toxicologist (45161)
Job Purpose
Working with BGRC Syngene in the field of regulatory toxicology.
Job Description :
• 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, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ISO guidelines.
• To prepare research reports/ dossiers according to the international regulatory guidelines.
Candidate Profile
• MSc/MPharm/MVSc
• 1-3 Years
• 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
Additional Information
Experience : 1-3 years
Qualification : MSc / MPharm / MVSc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th March, 2023
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