Gorman, M.Sc. MTOPRA
Regulatory Science, Drugs & Biologics
Ann Gorman is currently Director, Regulatory Science, Drugs and Biologics at Voisin Consulting Life Sciences. As an experienced regulatory professional, Ann assists international clients in the design and implementation of global product development plans and associated regulatory strategy.
Ann has 20+ years of experience in the regulatory field, within pharma and consultancy, and has expertise in Drug Development and Lifecycle Management. Her experience in biotech products and new chemical entities has covered a range of therapeutic areas, including oncology, neurology, and analgesia. She has led EU regulatory submissions including Marketing Authorisation Applications (MAAs), major variations, orphan medicinal product designation (OMPD) applications and paediatric investigational plans (PIPs). She has had extensive experience in interfacing with the European Medicines Agency (EMA) and national European Health Authorities including scientific advice procedures, oral hearings and pre-submission meetings.
Ann’s most recent position was as Director, Regulatory Affairs in the Immuno-oncology group at Amgen Ltd where her responsibilities included leading the EU MAA activities for a first in class oncolytic virus. She has also held regulatory positions at a number of companies including Elan Pharma, Janssen Alzheimer Immunotherapy, Helsinn, Gilead, Kendle and Mundipharma.
Ann has a BSc degree in Chemistry from the University of Edinburgh and an MSc in Analytical Chemistry from the University of Loughborough, and is a Member of TOPRA.
She is based in the VCLS office in Camberley, UK.