Anna Somuyiwa is in the Life Sciences Regulatory Quality and Safety Practise based in London (UK). She has over 16 years’ experience specializing in European regulatory affairs, including product development, registration and commercialization phases for pharmaceutical and biotechnology companies.
Her focus is on interactions with the European Medicines Agency (EMA) and its committees and to obtain and maintain Centralised product licences for a variety of therapeutic areas. Anna has lead several project teams in the delivery of complex regulatory strategies and submissions, which have included Orphan Drug Designation, Pediatric Investigation Plans, Agency interactions and Marketing Authorisation Applications via the Centralised procedure, registration strategies for new indications and maintenance of a product with an Exceptional Circumstances MA. She has been involved in developing a regulatory strategy for product expansion, and leading development of a global dossier to supporting international Marketing Applications.
Anna has a BSc in Pharmacology with Management from King’s College, University of London, and a Postgraduate Diploma in Regulatory Affairs from the University of Wales. She is an experienced trainer, certified in DISC personality assessment and coaching/mentoring. She speaks Italian (native), and Yoruba (native).
BSc Pharmacology with Management, King's College of the University of London Postgraduate Diploma in Regulatory Affairs, University of Cardiff, Wales
TOPRA - The Organization of Professionals in Regulatory Affairs