Team Member - Toxicologist (GTI Risk Assessment)

Roles & Responsibilities
• Perform Genotoxicity Hazard Assessments for impurities using published or experimental in-vitro/in-vivo data and in-silico (Q)SAR tools as per ICH M7 guidelines
• Conduct nitrosamine evaluations to derive acceptable intake limits or perform read-across assessments based on current global regulatory guidelines
• Perform Toxicological Risk Assessments (TRA) for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products
• Interpret experimental toxicology data and integrate findings into regulatory risk assessment reports
• Support regulatory submissions in compliance with ICH, USFDA, EMA, CFDA, and DCGI guidelines
• Collaborate with cross-functional teams and external CRO partners for risk evaluation and documentation
• Manage multiple projects while ensuring adherence to timelines and quality standards
• Utilize QSAR tools, data mining software, and citation tools for comprehensive assessments

Qualification
• Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine, or related field OR
• Medicinal Chemistry background with experience in GTI evaluation, QSAR evaluation, and nitrosamine assessments

Experience
• 2–5 years of experience in toxicological risk assessment and experimental toxicology
• Experience within pharmaceutical, CRO, or biotechnology industry preferred
• Hands-on experience with ICH M7, genotoxic impurities (GTI), and nitrosamine risk assessments

Skills
• Strong understanding of global regulatory guidelines (ICH, USFDA, EMA, CFDA, DCGI)
• Expertise in QSAR tools and in-silico toxicology evaluations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and SharePoint
• Strong analytical, documentation, and problem-solving skills
• Effective project and timeline management abilities
• Excellent communication and cross-functional collaboration skills
• Detail-oriented with proactive planning capabilities

About the Company
Cipla is a leading global pharmaceutical company committed to providing high-quality, affordable medicines across therapeutic areas, with a strong focus on regulatory compliance, patient safety, and innovation.