Vi Stuart

Vi Stuart is an experienced Regulatory Affairs leader with over 20 years of experience in the global pharmaceutical industry. Her expertise spans major pharmaceutical companies, consultancies, and non-commercial organizations, where she has held strategic and senior leadership roles. Most recently, she served as Head of UK Regulatory Affairs at Roche UK, leading a team of 26 professionals and driving regulatory strategy and operations to support product development and commercialisation. 

Vi has a deep knowledge of UK, EU, and global regulatory procedures for both small and large molecules, with notable leadership in oncology and respiratory therapeutic areas. She has held key roles such as Global Regulatory Lead at Eisai (collaborating with Merck) and EU Regulatory Lead at GlaxoSmithKline for high-profile assets. Her experience includes navigating innovative regulatory pathways such as ACCESS, Project Orbis, ILAP, and the EMA PRIME scheme, as well as leading scientific advice procedures. 

Beyond product development, she is a passionate advocate for regulatory innovation, including decentralized trials and real-world evidence. Vi holds an MSc in Toxicology from the University of Birmingham and a BSc in Pharmacology from the University of Leeds.