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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 significant 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.

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