Isabelle is a Regulatory/QA executive with over 20 years of progressively responsible experience and accomplishments in the areas of drug and medical device development.
Isabelle has joined Merck since 2008 where she held growing managerial roles in Reg. Affairs and Reg. CMC as Head of Department, based in Switzerland.
Since 2014, she is very actively involved in regulatory policy as member of EFPIA, Europabio, IFPMA Regulatory Strategy Committee since 2015 and IFPMA representative at ICH Training SubCommittee.
In this respect, she has been a member of the WHO Expert Committee on Specifications of Pharmaceutical products as well as presenter at various DIA meetings on the topic of reliance and convergence. In June 2019 and September 2022, as EFPIA ICH Q12 representative, she presented opportunities and challenges of ICHQ12 at DIA US and RAPS Annual meeting.
In her current capacity as Director of International Global Regulatory Affairs & Scientific Policy, she leads the development of Merck International regulatory policy priorities and
advocacy agenda, supporting the strategic development of Merck R&D portfolio and life cycle management.
Prior to joining Merck, she worked for several Companies in several areas of small and large molecules including in Clinical Development for Servier Laboratories (France), and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA and Regulatory Affairs (and previous merged companies) for 7 years (in France).
Isabelle holds a Master’s degree in Biology and Medical Sciences (therapeutic chemistry) from Lyon University (France) and a Pharm. D from Lyon school of Pharmacy as Industrial Pharmacist, coupled with a Master in Quality Management from Paris High Business School (ESCP/EAP, France).