Person will responsible for Compilation/ review of supplements ( including Injectable and OSD dosage form) ,Global Annula reports, preparation of summary documents for regulatory submission

• Preparation, Review and Submission of Amendments and supplements for the assigned products
• Prepation of Summary documents for Regulatory submisison
• Preparation, Review and Submission of response to the Agency’s queries for the assigned products
• Compilation and submission of Global Annual Report.
• Review of stability protocols and reports, analytical method validation protocols and reports.
• Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
• Review of batch records.
• Review of Process Validation Protocol, hold time study protocols and Repots
• Review of Product Development Report
• Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement