Paul Smith

Senior Advisor 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. 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 deliver the best possible regulatory outcomes in the complex biotechnology, and more specifically regenerative medicine, environment. 

Before joining Promethera, Paul was Vice President at Tusk Therapeutics, as well as being a member of the leadership team, 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 which was responsible for Regulatory, Quality and Compliance in the Amgen affiliates, as well as leading the European Regulatory oncology team and serving in global senior leadership roles.

Paul holds a BSc in Biochemistry and Physiology from the University of Sheffield, UK.