-Preparation of Technical Dossier and Global Documentation as per ICH CTD format/ other country specific regulatory guidelines.
-Preparation of ANDA (Abbreviated New Drug Application) & submission of eCTD to USFDA with the FDA Electronic Submissions Gateway (ESG) system.
-Ensuring regulatory requirements to register a product in highly regulatory body (eg. FDA, MHRA, TGA, ANVISA, MCC, WHO etc.)
-Developing and writing clear arguments and explanations for new product registration and registration renewals.
-Provide updated regulatory information to respective concerns, follow up the implementation & review whether any change is implemented to respective functional areas.
-To review o...
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