About this role
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 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.