Sara Molatore PhD, Regulatory Affairs Consultant
Sara Molatore is a Regulatory Affairs Consultant, specialised in orphan and paediatric medicines. She has a proven track record of assisting clients with Paediatric Investigation Plan (PID) applications, defining PIP/PIP waiver/deferral strategies and has first-hand experience of taking applications through the PIP procedure to successful and efficient paediatric development strategy. Another focus of her work is the designation, development and marketing authorisation application of orphan drugs in the EU and US. Furthermore, her experience covers data/dossier review and gap analysis; preparation of an extensive range of regulatory documents and regulatory submissions in electronic Common Technical Dossier (eCTD) format to European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
A biologist by training, Sara has a PhD from the University of Pavia, Italy, on the genetic basis of colorectal cancer. Prior to transitioning to the regulatory affairs community, she spent nine years at the Helmholtz Zentrum Munich, Germany, as postdoctoral researcher focused on the molecular mechanism of neuroendocrine carcinogenesis. She has authored several peer-reviewed publications in cancer genetics and molecular biology.