Description Lead support emerging markets and Japan Canada ANZ filing for Biosimilars NCEs ANDAs Query responses audit support and lifecycle management Regulatory support for the filing of IND CTA to various regulatory agencies Maintenance of IND CTA through submission of protocol amendments addition of investigators EC approvals SAE report submission quarterly annual Report etc Interested Candidates Please share the resumes at manan hathi kashivindia com Requirements Education Masters in biotechnology Pharma- Regulatory Affairs Pharmaceutical Biotechnology Experience 12-15 Years Skills Exposure in Emerging markets Regulated Markets Regulatory guidance Dossier Preparation Biosimilars and NCEs