Date: 29 Oct 2025Location:Bangalore, KA, IN, 560099Division: Dedicated Centre
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
