Leona Fitzgerald

PhD, Senior Director, Regulatory Affairs

Leona has worked in oncology for 18+ years and, in her current role, reviews and provides technical advice to prepare regulatory submissions. Leona has lead several clients with a variety of product types, including NCEs, biosimilars, and biological products, through scientific advice procedures both nationally and with the European Medicines Agency to successfully negotiate and agree on clinical development plans. In addition Leona is aligned with the medical affairs research organization at PPD, providing regulatory subject matter expertise in support of all aspects of peri- and post-product approval.