Dr Darius-Jean Namdjou

Director, Senior Regulatory Lead at Phortas GmBH

Speaker

Dr. Darius-Jean Namdjou 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 and further professional training, Darius joined the headquarter of Grünenthal 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 and further RoW markets, covering the product portfolio of Grünenthal. Since August 2011, Darius lead Regulatory Affairs product teams, on a global level, for several of Grünenthal’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. This company is supporting clients of all sizes mainly in strategic interactions with US FDA and EMA, plus acting as a client’s Interim Regulatory Affairs expert and also in coordination of submissions in the new EU clinical trial portal CTIS.

Darius is a member of the Drug Information Association (DIA) and German Society for Regulatory Affairs (DGRA). He is also a contributor to the EFPIA/EFGCP EU-X-CT initiative on cross-border access to clinical trials. Darius is a regular speaker at conferences and a lecturer in Regulatory Affairs university study courses.