• Position: Assistant Manager/Deputy Manager/Manager
• Department: Toxicology and Nonclinical Development
• Location: Ahmedabad, Gujarat (Corporate Office)
• Qualification: BVSc/MVSc/M.Pharm/MSc and/or PhD in toxicology
• Experience: 7-12 years
• Required Skills:
  • Nonclinical studies design, conduct, interpret, and/or outsource to CROs
  • Familiarity with generics (505b2 NDA) requirements on regulatory nonclinical studies
  • Impurity qualification as per ICH requirements
  • Toxicology risk assessment of drugs, impurities, and excipients
  • Leachable and extractable toxicological risk assessment
  • Genotoxicity assessment of drugs/chemicals/impurities – PDE/OEL determination
  • Experience in addressing regulatory agency queries, involved in non-clinical study execution & audit
• Application Deadline: 15th July 2024

Interested candidates should send their CVs to kavitriy@amneal.com