Apply for Regulatory Toxicologist in Syngene International Ltd.

An organisation that focuses on innovation, Syngene  provides complete scientific services from the earliest stages of discovery to commercial supply. Safety is the cornerstone of all we do at Syngene, both personally and professionally. Safety is now treated equally with business performance at Syngene, with shared responsibilities for following safety policies, procedures, and SOPs in letter and spirit.

Vacancy Name: Regulatory Toxicologist

Education: MSc / MPharma / MVSc

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

Role Accountabilities

• Conducting literature search and preparation of Toxicological assessment for Chemicals/ Pharmaceuticals / Medical devices E&L.
• Preparation and review of Nonclinical overview (NCO) for CTD submission of dossier filing.
• Preparation and review of Health Based Exposure Limits (PDE/ OEL/ ADI) reports for Pharmaceuticals/ Chemicals.
• Preparation and review of in silico toxicity prediction reports and ICH M7 genotoxicity reports
• Scientific literature search to extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like PubMed, ScienceDirect etc. 
• Evaluation of quality of different toxicity studies (such as systemic toxicity, genotoxicity, irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ ISO/ EPA guidelines.
• Preparation of Risk Assessment reports for Extractables and Leachables including calculation of Tolerable Intake in line with ISO standards.
• Preparation of Safety Data sheet in compliance with GHS.
• Preparation of research reports/ dossiers according to international regulatory guidelines.
• Preparation and review of reports for non-clinical studies conducted as per ICH/ OECD/ ISO 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: 3-6 years

Skills and Capabilities

• Scientific literature search to extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases e.g. PubMed, ScienceDirect etc. 
• Experience with preparation of toxicological assessment documents for Chemicals/ Pharmaceuticals / Medical devices E&L.
• Awareness of various approaches in risk assessment including Read-across approach, TTC approach
• Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
• Experience with preparation of Health Based Exposure Limits (PDE/OEL/ADI) reports for Pharmaceuticals/ Chemicals.
• Experience with preparation of Risk Assessment reports for Extractables and Leachables including calculation of Tolerable Intake in line with ISO standards
• Preparation of Safety Data sheet in compliance with GHS.
• Experience with preparation of in silico toxicity prediction reports and ICH M7 genotoxicity reports
• Evaluation of quality of different toxicity studies (such as systemic toxicity, genotoxicity, irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ISO guidelines.