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Bangladesh Bangladesh

Executive,Global Regulatory Affairs

Medical / Health Care / Pharmaceuticals

-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...