Syngene MPharma Regulatory Toxicology Job Opening – Apply Online
Regulatory Toxicology (55887)
Requisition ID: 55887
Posted 04/10/2024 – India
Job Description
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene’ s quality standards at all times
Core Purpose of the Role:
Working with BGRC Syngene in the field of regulatory toxicology.
Role Accountabilities
- 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.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience
- Demonstrated Capability
Education Experience
2-6 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
Education
MSc/MPharm/MVSc
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