David Nakar's Email and Phone

Manager, Clinical Program Management @ Edwards Lifesciences

David Nakar's Email

v****n@hotmail.com

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Location	Ra'ananna, Central, Israel
Work	Manager, Clinical Program Management @ Edwards Lifesciences Director Regulatory Affairs @ Chiasma Director Regulatory Affairs @ Kamada Ltd. RA manager @ Omrix biopharmaceuticals Research Consultant @ Philips Electronics Research Assistant @ Solvay
Education	Post Doc, Biotechnology, Molecular Biology @ Weizmann Institute of Science PhD, Biotechnology, Microbiology and Molecular Biology @ Tel Aviv University MSc, Food technology @ Wageningen University
About	David joined Chiasma, Israel in November 2012, where he is Director Regulatory Affairs. Previously he held senior Regulatory Affairs positions at Kamada Ltd. and Omrix biopharmaceuticals, Israel. He graduated as a Food Technologist (MSc) at the University of Wageningen, The Netherlands. In 2001 he obtained his Ph.D. degree at the Department of Molecular Microbiology and Biotechnology, Tel-Aviv see more David joined Chiasma, Israel in November 2012, where he is Director Regulatory Affairs. Previously he held senior Regulatory Affairs positions at Kamada Ltd. and Omrix biopharmaceuticals, Israel. He graduated as a Food Technologist (MSc) at the University of Wageningen, The Netherlands. In 2001 he obtained his Ph.D. degree at the Department of Molecular Microbiology and Biotechnology, Tel-Aviv University, Israel. From 2001-2005 he was a Post Doc. at the Department of Biological Chemistry at the Weizmann Institute of Science, Israel. Specialties: • Preparation of regulatory submissions: BLA, NDA 505(b)2, IND, MAA, orphan drug application • US & EU regulatory requirements • Strategic input into drug development programs • Management of regulatory affairs Department • Negotiating with regulation authorities • Review of key regulatory documents Clinical and Regulatory Affairs Project Manager @ From July 2014 to Present (1 year 6 months) Director Regulatory Affairs @ From November 2012 to April 2014 (1 year 6 months) Director Regulatory Affairs @ From July 2010 to October 2012 (2 years 4 months) IsraelProduct Manager Regulatory Affairs @ From October 2007 to June 2010 (2 years 9 months) IsraelRA manager @ From March 2005 to September 2007 (2 years 7 months) IsraelResearch Consultant @ From July 2004 to December 2004 (6 months) Research Assistant @ From 1995 to 1996 (1 year) Research Assistant @ From 1995 to 1996 (1 year) Research Assistant @ From 1995 to 1996 (1 year) David Nakar is skilled in: Regulatory Affairs, Biotechnology, Biopharmaceuticals, GMP, Regulatory Submissions, Validation, Quality Assurance, FDA, Process Validation, Lifesciences, V&V, Regulatory Requirements, Clinical Trials, Drug Development, R&D