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Compilation-Regulatory Affairs-RA

ConfidentialVadodara

27 days ago

Job description

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Senior Executive / Assistant Manager based at our Corporate Office - Vadodara , Gujarat.

Job Criteria :

B.Pharm or M.Pharm qualification having experience between 3 - 10 yrs. with compilation experience in US and Canada Countries.
Good communication skill

Job Responsibility :

Should have experience for compilation of documents for filing in US and Canada market.

Should have knowledge of ICH, USFDA and Health Canada guidelines, good understanding for review of executed documents.

Knowledge for review of analytical document, experience to respond agencys deficiency.

Skills Required

Regulatory Affairs, analytical review

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Compilation-Regulatory Affairs-RA • Vadodara