Agm Gra (regulatory Affairs)
Year GJ, IN, India
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
manan.hathi@kashivindia.com
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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Job Detail
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Job IdJD4356280
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationGJ, IN, India
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EducationNot mentioned
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ExperienceYear