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4.0 - 8.0 years

6 - 8 Lacs

navi mumbai

Work from Office

Dear All, We have opening for Regulatory Affairs (Formulations) - Executive / Sr. Executive where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Experience of handling M4 & M5 in Regulatory Affairs is must. Role & responsibilities 1) Thorough knowledge of Module 4 & Module 5 2) Preparation of required modules. 3) Document preparation for BE, NOC, TL, Import Permission applications for R&D procurement. 4) Follow up with the CRO for tracking BE study milestones and all other relevant activities. 5) Reviewing of the BE protocol, report. Education - B.Pharm / M. Pharm Desired Skills Strong understanding of CTD Modules 4 & 5 (Non-clinical ...

Posted -1 days ago

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