AGM-GRA (Regulatory Affairs)Kashiv BioSciences LLCfull-timeRequired skillsbiotechnologyAbout the role Website: kashivbiosciences.com Job details: Job TypeFull-timeDescriptionLead/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 anjali.joshi@kashivindia.comRequirementsEducation: Masters in biotechnology /Pharma- Regulatory Affairs/Pharmaceutical BiotechnologyExperience: 12-15 YearsSkills: Exposure in Emerging markets, Regulated Markets, Regulatory guidance, Dossier Preparation, Biosimilars and NCEs Click on Apply to know more. This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.