Francesca Buttigieg is a seasoned regulatory affairs professional with over 15 years of specialised experience in pharmaceutical and biotechnology regulation.
Career Highlights
Throughout her career, Francesca has demonstrated exceptional leadership in complex regulatory environments across multiple therapeutic areas. She has successfully led MAAs for innovative therapies, including cell therapies and oncology products, managing critical regulatory milestones and health authority interactions. Her expertise spans from finalizing regulatory submissions and establishing compliance processes to preparing teams for crucial regulatory committee meetings and oral explanations.
Francesca has served as Global Regulatory Lead for oncology products targeting rare diseases, successfully leading international regulatory teams and conducting health authority interactions with the FDA, EMA, and PMDA. She has secured clinical trial approvals across multiple regions with her strategic leadership often accelerating submission timelines and delivering significant business impact.
Her work extends to cutting-edge gene therapy development, where she has guided teams through complex regulatory procedures for first-in-human trials. She has pioneered the use of Real World Evidence for conditional approval pathways and successfully managed submissions while coordinating complex product divestment strategies.
Throughout her progressive career at leading pharmaceutical companies, Francesca has built expertise in managing several key submissions, conducting due diligence, and implementing registration strategies across markets.
Education and Professional Development
Francesca's academic foundation combines pharmaceutical science with specialized regulatory expertise. She earned her Bachelor of Pharmacy from the University of Malta, followed by an MSc in Pharmacotherapeutics and Medicines Management from the University of Sunderland. Her commitment to regulatory excellence is demonstrated by her MSc in Regulatory Affairs from the University of Wales/TOPRA, achieved with distinction.
Professional Contributions
Beyond her corporate roles, Francesca actively contributes to the regulatory affairs profession through her membership in TOPRA, where she has served as a Member of the Annual Symposium organizing committee. This leadership role demonstrates her commitment to advancing the profession and sharing knowledge with the broader regulatory community.