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Senior Manager

Dholka, GJ

Job Description

New Product evaluation and regulatory assessment as per WHO PQ and Russia - CIS.  To review Registration and Requalification Dossiers before submission in WHO PQ and also its expansion in other emerging market requirement as per collaborative procedure.  To review Registration and Re-Registration Dossiers before submission in all CIS countries.  To maintain Country-wise registered products status for all CIS countries.  To co-ordinate with other departments R&D, QA and QC for ensuring the filling and Query responses.  To provide technical support to team for preparation of Registration/Re- registration dossiers and Query responses.  To prepare and review documents for Variation filling as and when required for all CIS countries.  To clear issues of Commercial Orders related to Regulatory department for CIS countries.  To guide and give support for tenders to International SBU as per regulatory requirement (if any) for CIS countries.  To review and resolve queries related to Contract manufacturing product.