Dr. Abdelouahid Elkhattouti
About Dr. Abdelouahid Elkhattouti
Dr. Abdelouahid Elkhattouti is a Regulatory Affairs Manager at Fresenius Kabi in Bad Homburg, Germany, with extensive experience in regulatory submissions and compliance. He holds a Ph.D. from the University of Düsseldorf and has worked in various academic and research roles in the United States and Germany.
Work at Fresenius Kabi
Dr. Abdelouahid Elkhattouti has served as the Regulatory Affairs Manager at Fresenius Kabi since 2016. In this role, he is responsible for managing regulatory submissions and ensuring compliance with relevant regulations. He utilizes electronic submission tools such as CESP, eCTD Manager, and the EMA repository/web portal to facilitate the submission process. His work involves preparing approval dossiers, particularly focusing on Modules 1, 2, and 3 for generic intravenous drugs and tablets. Dr. Elkhattouti also represents the Regulatory Affairs department in project teams, contributing to the development of regulatory strategies.
Education and Expertise
Dr. Elkhattouti holds a Doctor of Philosophy (Ph.D.) from the Institute of Hemostasis and Transfusion Medicine, which he completed at the University of Düsseldorf from 2007 to 2011. He also earned a Master's Degree in Biology/Biological Sciences from the same university between 2000 and 2006. Additionally, he obtained a Master’s Degree in Drug Regulatory Affairs from Rheinische Friedrich-Wilhelms-Universität in Bonn from 2015 to 2017. He has an Associate’s Degree in Business Administration and Management from Millsaps College, which he completed from 2013 to 2014.
Background
Before joining Fresenius Kabi, Dr. Elkhattouti worked at the University of Düsseldorf as a Postdoctoral Fellow I for 11 months from 2011 to 2012. He then transitioned to the University of Mississippi Medical Center, where he served as a Postdoc Research Fellow II from 2012 to 2015 and later as a Guest Lecturer from 2014 to 2015. His experience in academic and research settings has contributed to his regulatory expertise in the pharmaceutical industry.
Regulatory Affairs Responsibilities
Dr. Elkhattouti is skilled in coordinating European regulatory procedures, including Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and Regulatory Update Procedures (RUP). He monitors the regulatory environment to ensure compliance with legal standards and to maintain a strategic advantage. His role involves engaging in correspondence with health authorities to address issues or clarify interpretations during the dossier submission process.