Claire Monnier

Managing Member

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, 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

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

Languages
Mother tongue: bilingual French/German
Fluent in English
Italian (spoken language)