Job Description

Compilation, review and submission of registration dossiers in the regions of South East Asia Handling of regulatory queries/deficiencies across all the South East Asia countries Submission of Supplements/Variations across all the South East Asia countries Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols etc. and Review and approval of Change Controls & Deviations Ensure availability of current guidelines for South East Asia Establish co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within period Submission of various original documents for notarization, chamberization and legalization, which forms an important part of dossier Arrangement of Samples, Packing Material, Impurities, Reference Standards as per MOH requirement Preparation of COPP's (Certificate of Pharmaceutical Product) and FSC submit to Local FDA approvals Any other assignments as specified by the reporting authority from time to time