Dr Julie Warner is Vice President of Regulatory Affairs and leads the award-winning regulatory team, supporting clients across the globe.
An experienced regulatory professional, Julie completed her PhD in 2002 at the University of Newcastle. After spending some time in research at the University of Cambridge and the biotech company AdProTech, Julie then joined Gregory Fryer Associates (GFA) in 2003.
As a Regulatory Consultant at GFA, Julie co-ordinated and managed projects on behalf of clients, ranging from EU and US orphan drug designation applications, to Protocol Assistance/ Scientific Advice, multinational clinical trial applications and marketing authorisation applications. During this time, Julie provided strategic and operational regulatory support for the programmes and managed interactions and negotiations with regulatory authorities in both the EU and US.
In 2008, Julie joined Genzyme Europe Research in Cambridge where she was responsible for their cardiovascular portfolio, taking a novel therapy from mid-stage clinical development through to marketing authorisation application.
From there, she moved to Clovis Oncology UK and was responsible for preparing and maintaining regulatory submissions for the product portfolio. In 2013, Julie was appointed Senior Regulatory Programme Manager at Roche Products, working on an oncology development project.
Julie joined Boyds in August 2014 to strengthen the existing regulatory affairs team and in 2016, she became Director of Regulatory Affairs. Bringing a wealth of experience in EU and US regulatory affairs, Julie has a special interest in orphan drugs.
Julie has been a member of the Editorial Panel for the professional journal of The Organisation for Professionals in Regulatory Affairs (TOPRA), the Regulatory Rapporteur, for over 10 years, and in 2015 became a Fellow of TOPRA.