Sr Executive/ Assistant Manager ( male preference )
B Pharm/ M Pharmgraduate
Preparation & submission of regulatory documents and ensuring compliance with Emerging & regulated markets.
Handling queries related to dossier from clients & regulatory authorities.
Review all documents as per Guidelines (ICH, WHO, Specific etc.)
Ensure that all requirements meet the client & market requirements.
Coordinating effectively with all cross functional terms to produce the documents required for compilation of dossiers.
Create and manage the dossier plan(s)/ submission packages in line with the regulatory strategy.
To reply the queries raised by clients or regulatory bodies for post approval changes.
Review the technical documents (AMV, PV, BMR, SPEC STP and CDP etc) and legal documents.
To handle responsibilities of legalization, aposillation and tracking for department purpose of legal documents (Product permission, certificate of pharmaceutical Product permission, FSC, Cover latter and Letter of authorization).
Job Type: Full-time
Pay: ?45,000.00 - ?55,000.00 per month
Work Location: In person
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