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AGM-GRA (Regulatory Affairs) at Kashiv BioSciences, LLC

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

25 Dec, 25

Salary

0.0

Posted On

26 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Exposure In Emerging Markets, Regulated Markets, Regulatory Guidance, Dossier Preparation, Biosimilars, NCEs

Industry

Pharmaceutical Manufacturing

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

Responsibilities

Lead and support regulatory filings for Biosimilars, NCEs, and ANDAs in emerging markets. Provide regulatory support for IND/CTA submissions and maintain IND/CTA through various amendments and reports.