- 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