International Markets Regulatory Affairs Senior Specialist, MSc.

İbrahim Etem Menarini - Regulatory Affairs Senior Specialist April 2020 - Present - Follow-up the registration steps. - Monitoring reporting and setting timelines for the variations, renewals and databases. - Ensuring the consistency of HA approved RA information throughout other units. - Initiating the process for HA approved packaging materials. - Planning and management of prioritization process for GMP and MA submission. Deva Holding - International Markets Regulatory Affairs Senior Specialist July 2013 – April 2020 - Preparation and submission of Common Technical Document (CTD) dossiers according to the concerned authority regulations (CIS, MENA and different countries) - Follow up the submitted files, updates/ variations / renewals throughout registration process. - Monitoring and following up deficiency letters coming from health authorities. - Tracking updates in regulations and managing the documentation accordingly. - Preparing variation documents for dossier changes according to the relevant guidelines. - Preparation of artworks (outer box and inner label) - Preparation ASMFs of APIs. - Coordination of CEP application of APIs to EDQM and follow-up the whole process. Ali Raif Pharmaceuticals - R&D Specialist Nov. 2008 – July 2013 - Generated analytical methods for 10+ new products in R&D Department. - Prepared technical parts (Module 3) of CTD. - Played active role for researching formulations of 5+ new generic products in R&D Department