Preparation of registration dossiers in ASEAN CTD format Interpreting regulatory guidance of ASEAN countries. Addressing country specific regulatory requirements Submission of various original documents for notarization, chamberization and legalization Arrange drug product samples, Packing Material specimen, Impurities, Reference Standards as per country requirement Coordinate with other departments like QA/QC, R&D, Marketing and Purchase for regulatory documentation Post approval activities: Submission of renewal applications and variations as required Preparation of COPPs (Certificate of Pharmaceutical Product) and FSC. Preparation of Tender documents Self-awareness about changing regulatory requirement Extend similar support for other regions on need basis
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