Curriculum Vitae
Claire-Andrée Monnier
Regulatory Affairs Consultant

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 leading to the title of “University Professional in Pharmaceutical Medicine (UP)”, 2009

Summary of experience
Technical background with more than 19 years regulatory affairs experience in the pharmaceutical industry. Extensive understanding of all aspects of the FDA (CBER) regulatory processes specifically in the product registration of sterile biological preparations as well as production plant submissions. Experience in European Licensing Procedures.

Experience
2001 - present REGULIX LTD, Switzerland
Foundation of own company in 2001 after more than 9 years spent in the pharmaceutical industry. Responsibilities include offering national and international regulatory affairs consultancy, specifically in the field of product registration of sterile preparations, biological products, vaccines as well as registration of production plants (IND, BLA, CTD, IMPD etc.).

2000 - 2001 ZLB Zentrallaboratorium BSD SRK, Switzerland
(A Foundation of Swiss Red Cross, manufacturing biological products sold worldwide) from 09/00 called ZLB Bioplasma AG and sold to the Australian company CSL Ltd.
Head Drug Registration and Regulatory Affairs (DRRA)
Responsibilities included management of the DRRA department (job function same as below). DRRA project manager for the <integration project> after takeover by <CSL Australia>

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

  • Management of the DRRA department
  • Compilation of dossiers for USA (BLA, IND)
  • Presentations of projects to the FDA and European Authorities (pre-IND, pre-ELA meetings)
  • Compilation of European Marketing Authorization Applications and national applications
  • Dealing with Health Authorities (international & national)
  • Developing regulatory strategy plans
  • Responsible for regulatory input into the development program for new products or plants
  • Providing support to the Marketing Department by writing promotion material
  • GMP inspections of Blood Banks (up to 1999)
  • Escort FDA GMP-inspections

1992 - 1994 ZLB Zentrallaboratorium BSD SRK, Switzerland
DRRA Manager

  • Compilation of dossiers for USA (PLA, ELA & IND)
  • Compilation of European Marketing Authorizations
  • Applications and national applications
  • Presentations of projects to the FDA and European
  • Authorities (pre-IND, pre-ELA meetings)
  • DRA project manager in international projects
  • Dealing with Health Authorities (international & national)
  • GMP inspections of Blood Banks
  • Internal GMP audits
  • Escort FDA GMP-inspections

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