Generics Company, Switzerland
He joined a major generics company based in Switzerland as Senior Global Regulatory Affairs Manager in February 2011. Prior to that, between 2008 and January 2011, he was Regulatory Affairs Manager at BioGeneriX AG / ratiopharm (TEVA) in Mannheim (Germany) managing regulatory activities associated with the development of investigational biosimilar / biobetter proteins. From 2004 – 2008 he served as Regulatory Affairs Associate in the Product Lifecycle division at CSL Behring AG, Bern (Switzerland) where he was responsible for assigned marketed human plasma products. Before that he worked in the regulatory affairs department at Chiron Vaccines, Marburg (Germany). He holds a master’s and doctoral degree in molecular cell biology from University of Goettingen (Germany) and did postgraduate research at the University of California at San Francisco (UCSF, USA). Recently he accomplished a postgraduate qualification in Drug Regulatory Affairs at University of Bonn (Germany).
Manfred Kurz has more than 10+ years experience in the biotechnology area with focus in Regulatory Affairs relating to biologics.
Specialities: Drug development and regulatory strategy (EU and Global), Biopharmaceutical Development (adjuvant cancer therapy, oncology, immunology), Life Cycle Management CMC aspects, Clinical Trial Applications (EU and non-EU countries),Scientific Advice Pediatric Investigation Plan (PIP).
Pharmaceutical Regulatory Affairs: Open Access received 471 citations as per Google Scholar report