Julie Warner

Regulatory Consultant, Boyds Consultants

Julie has extensive experience in the development and registration of novel technologies, focusing on regulatory strategies for registration and consultation with key regulatory agencies in the EU (EMA and national agency), US and Rest of World across all stages of development.

Over the last 8 years, she has supported Phase 1 to Phase 3 development programmes and in 2018/2019, led the preparation of a US Biologics License Application for a novel advanced therapy medicinal product in oncology. Most recently, she contributed to the development of a vaccine for prevention of Covid-19 infection.

Dr Julie Warner completed her PhD in 2002 at Newcastle University. After spending time in research at the University of Cambridge and the biotech company AdProTech, Julie joined Gregory Fryer Associates (GFA) in 2003 and, as a Regulatory Consultant. 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. Following her time at GFA, Julie joined Genzyme Europe Research, before spending two years at Clovis Oncology UK. Subsequently, Julie was appointed Senior Regulatory Programme Manager at Roche Products, working on an oncology development project.

Julie brings over 19 years’ experience in EU and US regulatory affairs to the team, and has been a member of the Editorial Panel for TOPRA’s professional journal, the Regulatory Rapporteur, for over 18 years. In 2015 she became a Fellow of TOPRA, and was a finalist in the 2018 TOPRA Awards for Regulatory Excellence.