Regulatory Affairs & PV Officer

Posted By Gulf Recruitments
Ali Abdulwahab Al Mutawa - Kuwait City - Purpose of Job: The RAO supports the Regulatory department in the registration of products for Pharma in the related matters. Essential Duties and Responsibilities: -Registration/ Renewal for new products/existing products for Pharma Registration/ Renewal of Principal companies in MOCI. -Obtaining approvals for the variations in the registered products. -Preparation and submission of dossiers to obtain new licenses for products in Pharma Dept. -preparation and submission for post approval variation. - Ensure that products under AAW distribution comply all the local regulations. -Reply to MOH for all their general questions,inquires & objections about the products. -liaise with business partners to accomplish all the above tasks. -Ensure the establishment & maintenance of AAW pharmacovigilance system. -Ensure that an adequate system is in place for the collection , processing & reporting to MAH\MOH on time. #LI- MH1...

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