Work History

Work History
Jul 2006 - Present

Regulatory Affairs and Quality Manager

Kenta biotech

Functions: Regulatory and Quality Affairs Manager, Swissmedic Qualified Person

Tasks: Regulatory Affairs

- Generation and implementation of regulatory strategies for development ofbiologicals (Monoclonal antibodies for human use)

- Generation and implementation of a regulatory strategy for the development of a companion diagnostic PCR kit (personalized medicine)

- Close contacts and networking with relevant national competent authorities and main

regulatory bodies in Europe and US (EMA, PEI and FDA)

- Preparation of Scientific Advice Meetings with main regulatory bodies in Europe and US (EMA, PEI, AFssaps, FDA)

- Compilation/co-ordination/submission of regulatory dossiers (e.g. IMPD, IND, Orphan Drug designation) and packages for/to regulatory agencies

- Input into pre-clinical/clinical product development and manufacturing strategies regarding specific regulatory requirements

Quality Affairs (Swissmedic Qualified person)

- Generation, implementation and maintenance of a GMP Quality system for storage, distribution and release of investigational medicinal product (IMP)

- Controlling of adherence of internal quality assurance activities and activities of external partners (audits) and ensuring the compliance with EU, FDA and national laws, directives and regulations

- Organise globally and ensure final release of IMP

Coordination of Project Management for drug development

- Generation, implementation and maintenance of a Project Management system

- Organisation and preparation of periodic project review meetings with project leaders and executive management

Oct 2001 - Jun 2006

Regulatory Affairs Manager


Function: Regulatory Affairs Manager

Tasks:- Global regulatory management (CH/EU/Asia) of an influenza vaccine (biological product, sales growth 2001-2005: 224 % ), global regulatory compliance (variations).

- Regulatory management and advisory in development projects (Phase 1 and 3), scientific advice meetings in CH/EU.

- Regulatory management and advisory for international partner companies.

Mar 2000 - Dec 2000

Product Manager Oncology

Aventis Pharma Switzerland

Function: Product Manager TaxotereÒ (Chemotherapy)

Tasks:- Generation of literature dossiers and promotion material for patients/nurses/doctors

- Establishment and maintenance of a competition surveillance system

- Generation and maintenance of a sales reporting system for the franchise products

May 1999 - Feb 2000

Junior Product Manager Rheumatology

Abbott Pharma Switzerland

Function:Junior Product Manager Rheumatology

Task:Launch of a NSAID on the Swiss market: market survey, promotion strategy, promotion material for doctors/patients, generation of literature dossiers, supervision and training of sales force, competitors‘ surveillance.

Feb 1998 - Mar 1999

Business Organisator, Dpt. payment transactions and investigations

Credit Suisse

Function: Assistant to the head of department.

Tasks:- Take-over and development of operative reporting of the department.

- Implementation and maintenance of different electronic leading tool: MIS, quality management systems.

- Enforcement/implementation of transfer, new organisational structure and pooling of several operation/cost centres (logistics, layout, know-how management)


1993 - 1997


Swiss Institute of Technology
1992 - 1992


Boston University Medical Center
1987 - 1991


University of Fribourg


2006-2008: Deutsche Gesellschaft für Regulatory Affairs

Since 2008: Drug Information Association

Since 2008: European QP Association

Since 2009    : TOPRA (MTopra)

Courses/conferences (recently attended)

2006: Workshop Orphan Designation, 2006 Annual EuroMeeting, DIA, Paris 2006: Biological Assays, Development and validation, 17-18 October 2006, Munich 2007: Comparability for Biologics, Berlin, 25-27 June 2007 2007: 2007 BioReliance Technical Seminar, 15 novembre 2007, Basel 2008: IMPD für biotechnologische Arzneimittel, Frankfurt, 29 february 2008 2009: GMP in Research and development, Karlsruhe, 17-18 February 2009 2009 : 21 st DIA Annual EuroMeeting, March 23-25 in Berlin 2010 : BioReliance Technical Seminar, Strasbourg, 4 March 2010 2010 :Qualified Person Forum 2010, London UK, 25-26 November 2010

2011 : CMC Regulatory Compliance for Biopharmaceuticals and Biologic, Berlin, 20 March-1 April


As an all-rounder and hands-on Regulatory affairs/Quality professional in the field of biologicals (human mAbs),

I love being in a start-up company. Because there I can do what I am best at: explore, develop and structure. My professional focus are global regulatory affairs (EMEA and FDA), CMC, drug development and quality issues for biologicals. Newly I also had to take care of our companion diagnostic project.Here are my main achievements at Kenta Biotech since 2006:

2006: EMEA and FDA Orphan Drug Designation for a therapeutic human MAb

2007: Implementation of a GMP quality system, granting of an establishment licence for Kenta Biotech, appointment as Swissmedic qualified person

2008: Implementation of a project management organization

2010: First elements of a PIP strategy

2010: Elaboration of a global regulatory strategy for a drug-companion diagnostic project (personalized medicine)

2011: Organisation of scientific advice meetings with Afssaps, MHRA, PEI in view of a phase I trial in pneumonia patients

2011: preparation of the IMPD of a human mAb to be used in a phase I clinical trial in pneumonia patients

2011: preparation for 5 CTA procedures in 5 large EU countries

Language skills

Frensh : native language

Deutsch : business-fluent written and spoken

Englisch : business-fluent written and spoken


Contribute to make out of Kenta Biotech the next Genentech


Spend time with my family, read good thrillers (Robert Crais, Michael Connelly, Henning Mankell), follow the ride of my (few) investments in stocks and read financial news, watch any episode of the TV show "Friends", read everyday the 2 best newspapers in the world (Le Monde and the International Herald Tribune)