AGM-GRA (Regulatory Affairs)
Kashiv Biosciences LLC · Ahmedabad, Gujarat, INDIA
Description - Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs, - Query responses, audit support, and lifecycle man...
Job description
Description: Interested Candidates Please share the resumes at anjali.joshi@kashivindia.com - 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. 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