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Darius-Jean Namdjou, PhD (he/him/his)

Director, Senior Regulatory Lead
Phortas GmbH
Aachen, Nordrhein-Westfalen, Germany

Dr. Darius-Jean Namdjou, Director, Senior Regulatory Lead at Phortas GmbH, Germany graduated as Ph.D. chemist from Aachen University, Germany, in 2006. After a two year Post-Doc stay at the National Research Council in Ottawa, Canada, Darius joined the headquarter of Grunenthal GmbH, Aachen, Germany as Regulatory Affairs Manager in 2009. Darius gathered two years experience with the coordination of marketing authorization and lifecycle activities in emerging markets, covering the product portfolio of Grunenthal. Since August 2011, Darius led Regulatory Affairs product teams, on a global level, for several of Grunenthal’s development and established pain products. He further specialized himself on the Regulatory Affairs part of Due Diligence projects.
From 2021-March 2024, Darius took on a new challenge by joining the clinical stage biotech company Immunic AG in Munich, Germany, specialized in autoimmune and inflammatory diseases. Darius lead the Regulatory Affairs (RA) and Pharmacovigilance (PV) team for the company. In this role, he built up the internal RA and PV team from scratch, while also selecting, managing and further strengthening the relationship to vendors specialized in the respective fields.
Since April 2024, Darius is working as Director, Senior Regulatory Lead at the specialist RA and Development consultancy Phortas GmbH, Aachen, Germany. Phortas is supporting clients of all sizes mainly in Gap Analysis of Development programs, strategic interactions with US FDA and EMA, as well as Marketing Authorization submissions plus acting as a client’s team-embedded Regulatory Affairs Lead.
Darius is a member of the Multistakeholder Advisory Board of the EU Rare Diseases Research Alliance (ERDERA). He is also a member of the Core Management Team of the EFPIA/EFGCP EU-X-CT initiative on cross-border access to clinical trials. He is a regular speaker at conferences and a lecturer in Regulatory Affairs university study courses.

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