Executive
Job Description
1. Preparation and submission of registration and re-registration dossiers as per country requirements i.e. African countries, FWA countries and Nepal
2. Submission of various original documents for notarization, chamberization and legalization which forms an important part of dossier.
3. Arrangement for Indent of Samples, Packing Material specimen, Impurities, Reference Standards as per MOH requirement.
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. Enhance self-awareness about changing regulatory requirements.