Preparation and compilation of dossier(s) of Finished Product in CTD and ACTD format for ROW countries.
To prepare registration dossiers for various other countries as per country specific regulatory requirements.
To prepare & submit complete & accurate registration / re-registration documents & samples well within time & to reply to queries as may be raised by registration authorities.
To co-ordinate for samples to be submitted for registration.
Documentation, Review like MFR,PVR,AMV,STPs etc..
Coordinating with different departments regarding regulatory and quality compliance practices and for documentation.
Coordinating with relevant institutions regarding conduct of Bioequivalence studies, providing them with details of the innovator product and other specific requirements of the respective countries.
Providing guidelines for developing Packaging and Labels as per Global Labeling.
Search and retrieve the different registration guidelines and to keep the same as a data bank for ready reference (Database Management)
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