Stuck in your process flow?
Have you thought about REGULIX LTD?

Claire & Esther under the atomic microscope 2017, Photos: Thomas Cunz

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 bank Internal GMP audits Escort FDA GMP inspections  

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


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 20 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 BDS SRK, Switzerland Head Drug Registration and Regulatory Affairs (DRRA), Assistant to the Vice-President QA 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 meeting)  Compilation of European Marketing Authorization Applications and National Applications Negotiation with Health Auhtorities (international & national) Responsible for regulatory strategy plans incl. new products or manufacturing plants Providing support to the Marketing Department by writting promotional 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) and European Marketing Authorizations National Applications Presentations of projects to the FDA and Euopean Agencies (pre-IND, pre-ELA meetings) DRA project manager in international projects Negotiation wiht Health Authorities (internat. & national) GMP inspections of Blood Banks Internal GMP audits Escort FDA GMP-inspection.

Language skills
Mother tongue: French (billingual French/German)
Fluent in English,  Italian (spoken language), Japanese (tourist level)