VP Regulatory Affairs
Paul Smith is a seasoned regulatory affairs professional with 30 years’ experience in drug development and over 20 years in the biotechnology sector at Amgen and Tusk Therapeutics. He has extensive experience across all areas of drug development (CMC, preclinical and clinical) and provides bespoke regulatory services to start up and established biotechnology companies for all aspects of product life cycle management.
Paul has a proven track record of developing successful regulatory strategies to maximize opportunities for accelerated product approval in both EU and US. His expertise will help us delivering the best possible regulatory outcomes in the complex biotechnology and more specifically regenerative medicine environment.
Before joining Promethera Paul was Vice President, as well as member of the leadership team at Tusk Therapeutics where he managed all global regulatory activities for Tusk's immune oncology antibody portfolio. Prior to that he held several executive management positions at Amgen Ltd during a 19-year tenure where he led the Europe and International Regulatory Teams, responsible for Regulatory, Quality and Compliance in the Amgen affiliates, as well as the European Regulatory oncology team and also served in global senior leadership roles.
Paul holds a BSc Biochemistry and Physiology degree from University of Sheffield, UK.