Isabelle Colmagne-Poulard

Isabelle Colmagne-Poulard 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. She therefore has a solid practice of regulatory CMC requirements pre- and post-approval for small and large molecules and is used to represent Merck towards Health Authorities.

She is actively involved in regulatory policy as member of EFPIA, Europabio, and IFPMA RSC since 2015. In this respect, she represented IFPMA at various conferences in Asia, Europe, Middle East and Africa, has been a WHO ECSPP observer and is currently IFPMA representative at ICH Training Sub-Committee. In her current capacity as Head of International Global Regulatory Affairs & Scientific Policy, she leads the development of Merck International regulatory policy priorities, supporting the strategic development of Merck R&D portfolio. Prior to joining Merck, she worked for several companies in several areas including in Clinical Development for Servier and assumed various site managerial responsibilities within Sanofi QA/RA for 7 years. Isabelleholds a Master degree in Biology & Sciences and a Pharm. D as Industrial Pharmacist, coupled with a Master in Quality Management from ESCP Paris.