- Review and process change control proposals received from units, CCDC
- Co-ordinate with all stake holders for activities required for Implementation of post approval changes
-Track identified regulatory related actions in change controls, deviations.
- Identify & Device systems required to achive regulatory compliance in terms of SOP'S , Tracking system etc
- Perform internal regulatory compliance assessment at PRC, R&D, & Units, CCDC
- Prepare report for regulatory compliance assessment & follow up on actions identified
-Keep track of activities to be completed regulatory as part of regulatory commitment
-Identify learning from deficiencies & impart training to PRC associates on the learning's
-Prepare annual regulatory updates
-Perform file compliance check for Dossiers & DMF
CLICK HERE FOR MORE INFO
- Co-ordinate with all stake holders for activities required for Implementation of post approval changes
-Track identified regulatory related actions in change controls, deviations.
- Identify & Device systems required to achive regulatory compliance in terms of SOP'S , Tracking system etc
- Perform internal regulatory compliance assessment at PRC, R&D, & Units, CCDC
- Prepare report for regulatory compliance assessment & follow up on actions identified
-Keep track of activities to be completed regulatory as part of regulatory commitment
-Identify learning from deficiencies & impart training to PRC associates on the learning's
-Prepare annual regulatory updates
-Perform file compliance check for Dossiers & DMF
CLICK HERE FOR MORE INFO
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