Vinciane Wouters
About Vinciane Wouters
Vinciane Wouters is the Director of Global Regulatory Strategy EU Oncology at Bristol Myers Squibb, with extensive experience in regulatory guidance for Advanced Therapy Medicinal Products.
Current Position
Vinciane Wouters currently holds the position of Director Global Regulatory Strategy EU Oncology at Bristol Myers Squibb in Braine-l'Alleud, Région wallonne, Belgique. Her role involves leading the regulatory strategy for oncology products within the European Union, ensuring compliance with all regulatory requirements, and spearheading regulatory submissions.
Previous Roles at Bristol Myers Squibb
Prior to her current position, Vinciane Wouters served as Associate Director, Global Regulatory Strategy Europe at Bristol Myers Squibb from 2016 to 2021. In this role, she managed regulatory strategies for various pharmaceutical products within the European market, leveraging her extensive knowledge in regulatory affairs to streamline processes and ensure successful submissions.
Experience at Promethera Biosciences
Vinciane Wouters has held several positions at Promethera Biosciences, beginning as Regulatory Affairs Manager from 2011 to 2012. She then advanced to Senior Regulatory Affairs Manager from 2012 to 2015, and subsequently to Director Regulatory Affairs from 2015 to 2016. During her tenure at Promethera Biosciences in Mont-Saint-Guibert, she played a crucial role in regulatory strategy and compliance, handling submissions and liaising with regulatory authorities.
Education and Qualifications
Vinciane Wouters is well-educated, holding multiple degrees from the Université catholique de Louvain. She obtained a Master’s in Molecular Biology from 1996 to 2001, a PhD in Biomedical and Pharmaceutical Sciences from 2002 to 2007, and a Special Master's in Biomedical Sciences from 2003 to 2004. Her extensive educational background has provided her with a solid foundation in biomedical and pharmaceutical sciences.
Expertise in Regulatory Affairs
Vinciane Wouters has significant expertise in regulatory affairs, particularly in the area of Advanced Therapy Medicinal Products (ATMP). She has been involved in clinical submissions in both Europe and the US, specializing in pediatric drug development and orphan drug development. Furthermore, she has conducted Scientific Advice Procedures with Regulatory Authorities, ensuring the smooth progression of clinical trials and pharmaceutical developments.