Brussels Metropolitan Area
With over 30 years of global experience in the biopharma and biotech industry, I am a senior drug development executive who leads and manages the Global Regulatory Affairs and Patient Safety at Chiesi Group, a leading international research-focused healthcare company. As of January 2025 I am also the EFPIA Company Representative to the Management Committee and Assembly of ICH. My mission is to build regulatory capabilities for the future by focusing on people development, innovation, portfolio management, and operational excellence. I have a strong strategic mind-set and a broad global drug development experience across diverse therapeutic areas and product types. I lead through inspiration, coaching, and collaboration, with focus, direction, and an open mind. I am passionate about creating, driving, and implementing strategies for exciting and innovative new drug solutions and therapies. I have demonstrated experience in leading and managing large projects and teams in regulatory affairs and early to late stage drug development. I thrive in both small and large companies, and I enjoy building, inspiring, coaching, developing, and managing high-performing teams.
Leading the newly created Global Regulatory Affairs and Patient Safety group at Chiesi.
Leading and managing the Global Regulatory Affairs function in Chiesi, focused on people development, innovation, portfolio management and operational excellence to build global regulatory capabilities for the future.
Representative for EFPIA companies in the Management Committee and Assembly of the Int’l Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. ICH now includes 23 Members and 38 Observers. https://ich.org/
Head of Regulatory for Early Respiratory & Immunology portfolio in AstraZeneca.
Owner and founder of the company Wave and Rock. Wave and Rock is a life science consultancy focusing on helping pharma and biotech companies to accelerate and improve quality in development of new innovative therapies, particularly in overall program, clinical and regulatory development with an added focus on team leadership and interactions.
Head of Strategic Drug Development at ActoBio Therapeutics, a biotech company developing new drugs based on a unique drug delivery platform. Responsibilities include leadership of Program and Portfolio Management, Clinical Development, Regulatory Affairs, CMC and Quality across the portfolio of early stage pre-clinical and clinical product candidates.