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Syngene looking for Regulatory Toxicologist | M.Pharm, M.Sc apply

 

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Syngene looking for Regulatory Toxicologist

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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