Senior Consultant, Scientific Writing & Regulatory Affairs
Regulatory expertise in drug development of innovative medicinal products including advanced therapy medicinal products with experience in successful preparation of paediatric investigation plans/waiver, orphan drug designation and early access programme requests.
Her recent work included
Before joining BlueReg, Justine gained experience in European regulatory affairs during traineeships at the European Medicines Agency and at Alexion, a biotechnology company. She also developed scientific writing skills from her training as an engineer and as a medical writer in a small biotechnology company.
First author for the following publications
Contribution to the European Medicines Agency Project Report on Results of juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children (15 November 2017)
Master’s degree in International Drug Development and Registration
at Paris XI Faculty of Medicine
Engineer in Biochemistry and Biotechnologies
at French Engineering School of INSA de Lyon
Exchange student programme
Honours Degree in Biochemistry and Cell Biology, Aberdeen (Scotland)