Gabrielle was appointed to the Regulatory Affairs team in April 2018, having previously undertaken an Assistant Project Manager role for 18 months at Simbec-Orion.
Since this appointment, Gabrielle has developed an extensive and comprehensive range of specialist expertise in Phase 1 regulatory affairs within the UK.
Gabrielle has undertaken the preparation and management of submission dossiers for a range of studies, including First-in-Human, combined HV/Patient, complex, multi-part umbrella protocols, scintigraphy and GMO studies.
Gabrielle has key knowledge of regulatory and ethical guidelines within the UK and EU and utilises this to provide a streamlined and efficient approach to obtaining regulatory approval for clinical trial conduct, as wells as providing expert strategic input. In addition, Gabrielle represents Simbec-Orion as a member of the UK Phase 1 Advisory Group and has presented seminars as part of the HRA REC Development Scheme.
Gabrielle completed a BSc (Hons) degree in Biomedical Science, undertaking specialist modules in the areas of clinical and pharmaceutical research.
