Job Description
1. Preparation and submission of WHO PQ dossier and requalification dossiers and for Russia-CIS
countries.
2. Good understanding of regulatory guidelines and requirements
3. Experience with e-CTD submissions tools (e.g., PharmaREADY, LORENZ)
4. Submission of WHO PQ approved product expansion dossiers in other emerging countries with
collaborative procedure of WHO.
5. Submission of various original documents for notarization, chamberization and legalization
which forms an important part of dossier
6. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards
as per MOH requirement.
7. Establish co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for
ensuring the filings and query response within time frame.
8. Post approval activities: Submission of variations to the terms of marketing authorizations for
finished products as per respective variation guideline.
9. Preparation of COPP’s (Certificate of Pharmaceutical Product) and FSC to be submitted to Local
FDA approvals.
10. Preparation of Tender documents.
11. Knowledge of SAP and EPIQ software.
12. Enhance self-awareness about changing regulatory requirement.
13. To extend similar support for other regions on need basis.
14. Support for activities of contract manufacturing product
