Must exposure of EU member countries,very robust knowledge of CMC parts ( AMV ,STP ,CDP ,PDR ,MFR ,BMR as per ICH / Eudrakex) query resolution exposure must .
candidate also aware about BE study , stability review in appropriate manner.also aware cordinate with EMA regulatory body , product life cycly management.minimum 7 + experience only in DRA stringent country require .Candidate have idea about broad domain to resolve the query .SME of CMC part to review only DRA exposure candidate must consider

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Synokem Pharmaceuticals Ltd

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