Curriculum Vitae
Esther Imboden
Managing Member of Regulix LTD
Education
First State Examination in Pharmacy, University of Bern, Switzerland, 1986
Advanced Studies in Pharmaceutical Medicine at the European Center of Pharmaceutical Medicine, University of Basel, 2009
Summary of experience
Technical background with more than 28 years regulatory affairs experience in the pharmaceutical industry. Extensive understanding of all aspects of the European and Swiss Licensing Procedures and the FDA (CBER) regulatory processes specifically in the product registration of sterile biological preparations as well as production plant submissions. Broad experience in project management, GMP /GDP activities as well as safety data management (pharmacovigilance).
Since 2001
CEO, Regulix LTD, Regulatory Affairs Consultancy, Switzerland
1993 - 2001
Senior Drug Registration and Regulatory Affairs Manager, ZLB Bioplasma AG, Switzerland
1991-1993
Director of Drug Registration and Regulatory Affairs, ZLB Zentrallaboratorium BSD SRK, Switzerland
1988-1991
Assistant to the Vice-President of Quality Assurance Department, ZLB Zentrallaboratorium BSD SRK, Switzerland
Languages
Mother tongue: German
Fluent in English, French
Italian (spoken language)
Spanish (DELE2)