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AGM-GRA (Regulatory Affairs)

AGM-GRA (Regulatory Affairs)

Kashiv BioSciencesahmedabad, India
8 hours ago
Job description

Apply Job Type Full-time 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

Requirements

  • Education : Masters in biotechnology / Pharma- Regulatory Affairs / Pharmaceutical Biotechnology
  • Skills :  Exposure in Emerging markets, Regulated Markets, Regulatory guidance, Dossier Preparation, Biosimilars and NCEs
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    Regulatory • ahmedabad, India

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