Curriculum Vitae
Esther Imboden
Regulatory Affairs Consultant

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

Summary of experience
Technical background with more than 23 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 13 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.)

1993 - 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.
Drug Registration and Regulatory Affairs (DRRA) Manager
Responsibilities included:

  • DRRA project manager in international projects
  • 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 (according to Notice to Applicants)
  • Manager of a Mutual Recognition Procedure

1991 - 1993 ZLB Zentrallaboratorium BSD SRK, Switzerland
Head of Drug Registration and Regulatory Affairs (DRRA)
Responsibilities included:

  • Management of the DRRA department (job function same as above)

1988 - 1991 ZLB Zentrallaboratorium BSD SRK, Switzerland
Assistant to the Vice-President of Quality Assurance Department
Responsibilities included:

  • Compilation of dossiers for USA (PLA, ELA & IND)
  • Compilation of European Marketing Authorization Applications and national applications
  • Dealing with Health Authorities (international & national)
  • GMP inspections of Blood banks
  • Internal GMP audits
  • Escort FDA GMP inspections

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