JOB RESPONSIBILITIES Support the International SBU through various activities like preparation of registration, re- registration dossiers, query redressal and maintain updation of registration status for ASEAN countries (Region II). • 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 key 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.