
AGM-GRA (Regulatory Affairs)
2 days ago
- 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
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
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