curriculum vitae

Claire-Andrée Monnier
managing member of regulix LTD.

educationFirst
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 (DRRA), ZLB Bioplasma AG, Switzerland

1995 - 1999
Head Drug Registration and Regulatory Affairs (DRRA) and Assistant to the Vice-President of Quality Assurance Department, ZLB Zentrallaboratorium BSD SRK, Switzerland

1992 - 1994
DRRA Manager, Senior ZLB Zentrallaboratorium BSD SRK, Switzerland

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

curriculum vitae

Esther Imboden
managing member of regulix LTD.

educationFirst
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 (DRRA) Manager, ZLB Bioplasma AG, Switzerland

1991-1993
Director of Drug Registration and Regulatory Affairs (DRRA), 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)