AGM-GRA (Regulatory Affairs)

12 - 15 years

0 Lacs

ahmedabad gujarat

Posted:2 days ago| Platform: SimplyHired logo

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Skills Required

master's degree

Work Mode

On-site

Job Type

Full Time

Job Description

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 [email protected]

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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Kashiv BioSciences, LLC

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