Director, International Global Regulatory Affairs & Scientific Policy (GRASP)
Merck (EMD Serono in the US)
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 (EMD Serono in US) since 2008 where she held growing managerial roles in Reg. Affairs and Reg. CMC as Head of Department, based in Switzerland.
She has a solid practice of regulatory CMC requirements pre- and post-approval for small and large molecules in EU/US/Japan/China/Row.
Since 2014, she is also very actively involved in regulatory policy as member of EFPIA, IFPMA Regulatory Strategy Committee and ICH Training Sub-committee. She has represented IFPMA at various conferences and has been a member of the WHO Expert Committee on Specifications of Pharmaceutical Products. In June 2019, as EFPIA ICH Q12 representative, she represented Merck at the DIA US annual meeting highlighting ICH Q12 opportunities and challenges. 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 for 7 years (in France). She therefore acquired GMP field compliance expertise, facing FDA interaction during inspections. She is also familiar with medical device and combination products as she headed Global Regulatory Affairs and QA for Nestle Health Science (Switzerland).
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, France).
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Tuesday, September 13, 2022
2:00 PM – 3:00 PM MST