Urgent Search Regulatory Toxicologist

JOB DESCRIPTION Job Title Regulatory Toxicologist Department Safety Assessment Job Location Bengaluru About Syngene Syngene www syngeneintl com is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit 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 and team-members 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 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 reproductive and developmental toxicity toxicokinetic studies as per OECD ICH FDA ISO guidelines To prepare research reports dossiers according to the international regulatory guidelines Education MSc MPharma MVSc Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodation for qualified individuals with disabilities