Hadi Tarek Hamed

Regulatory Affairs OfficerFull Time

• Job Details:CTD/eCTD knowledge and their 5 modules with a huge interest to export Knowing the guidelines and studying requirements of the Gulf region & COMESA countries in order to export our products Preparing, managing, and approve packs labeling & artwork. Preparing all required files for product lifecycle to get the final registration license (Box inquiry, Naming, Pricing, Material importation, working standards, impurity & related substances purchasing, pilot batch & technical file preparation, stability, and Hard file) Studying EDA guidelines and always be updated to ensure our products launch and maintaining in the market (425/2015, 645/2018, 820/2018 pharmaceutical & biological, 343/2021) Reviewing & studying all biological & biosimilars guidelines and ministerial decrees for the new biological products launch and registration Set an SOP for getting and contacting, audit and approve suppliers for APIs and primary packing Reviewing WHO & ICH guidelines of CTD dossier preparation