Curriculum Vitae
Claire-Andrée Monnier
Managing Member of Regulix LTD
Education
First State Examination in Pharmacy, University of Bern, Switzerland, 1989
Advanced Studies in Pharmaceutical Medicine at the European Center of Pharmaceutical Medicine, University of Basel, 2009
Summary of experience
Technical background with more than 25 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
2000 - 2001
Director of Drug Registration and Regulatory Affairs, ZLB Bioplasma AG, Switzerland
1995 - 1999
Head Drug Registration and Regulatory Affairs and Assistant to the Vice-President of Quality Assurance Department, ZLB Zentrallaboratorium BSD SRK, Switzerland
1992 - 1994
Drug Registration and Regulatory Manager, Senior ZLB Zentrallaboratorium BSD SRK, Switzerland
Languages
Mother tongue: French (bilingual French/German)
Fluent in English
Italian (spoken language)