Sr. Executive / Assistant Manager, Toxicology | NCE

Job Description:

Responsibilities

•  Nonclinical safety and toxicology study design & execution -
•  Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology studies in alignment with GLP principles.
•  Select appropriate species, study duration, and endpoints based on pharmacology, pharmacokinetics and regulatory requirements.
•  Review study raw data, protocols, results and reports.
•  Oversee study execution, ensure data accuracy, and coordinate with CROs or internal cross functional teams.
•  Risk Assessment & Safety Evaluation - 
•  Analyse and interpret the safety and toxicology data and integrate findings with pharmacokinetics and pharmacodynamics to assess potential safety risks.
•  Perform toxicological risk assessments including PDE/OEL/ADI derivations, impurity/excipient qualification assessments, extractables & leachables evaluations, and safety margin calculations.
•  Conduct exposure assessments for process materials, impurities, metabolites, degradation products and excipients.
•  Regulatory & Documentation - 
•  Prepare and review high-quality safety and toxicology study reports, technical summaries, and nonclinical sections of regulatory submission documents (IND, NDA/MAA, ANDA, eCTD Modules 2.4/2.6 & 4, briefing books and IB, etc.).
•  Support regulatory filings to USFDA, EMA, DCGI, and other global agencies.
•  Draft and review regulatory query responses, briefing documents, and expert justifications.
•  Toxicology Informatics & Literature Research - 
•  Perform comprehensive literature searches using toxicity databases (e.g., PubMed, TOXNET, ECHA, HSDB, etc.,).

Qualification & Expeirence

• Master’s or PhD in Toxicology, Pharmacology, Veterinary Sciences, or related biomedical science discipline.
• 8-10 years’ experience in preclinical toxicology with at least 5 years as a Study Director in a GLP-certified facility.