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.