1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Preparation of COPP’s (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals. 7. Preparation of Tender documents. 8. Support for activities of contract manufacturing product
