Leslie Dowling

Leslie has worked in regulatory affairs since 1997, mainly in human medicines, but also encompassing medical devices and veterinary medicines.  She is experienced in managing multiple regulatory projects simultaneously, working in matrix organisations, both within small/medium pharma and as consultant/CRO with small/medium/large pharma clients.  She has CTA experience in Phase 1-4 studies, including first-in-human and paediatric studies, mostly in EU but also in eastern Europe, Israel and India; therapeutic area experience includes oncology, endocrinology, neurology, respiratory, rheumatology and HIV.  Leslie’s MAA experience includes new MA applications as well as post-registration maintenance and variations, mostly in the EU but also in the Americas, Middle East, Africa, and Asia Pacific.  MAA therapeutic area experience includes oncology, gene therapy, endocrinology, antibiotics, multiple sclerosis, haematology, dry eye syndrome, hypotension and veterinary anaesthesia.  Leslie has a particular interest in early phase clinical regulatory development, and has prepared orphan drug designation and PRIME applications, and scientific advice/protocol assistance packages.

Leslie is a current holder of the Regulatory Affairs Certification [RAC(EU)] credential, with triennial recertification maintained.  She is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and currently active as the Editor-in-Chief of the TOPRA journal Regulatory Rapporteur.  She is a member of the Regulatory Affairs Professionals Society (RAPS) and was a member and the Chair of the RAC(EU) Examination Committee.  She was a Shortlisted Nominee for the TOPRA Communication Award in 2016 and received a TOPRA Distinguished Service Award in 2017

Leslie has more than 8 years of experience in chemical analysis of natural rubber latex and synthetic polymer products, OTC pharmaceuticals, and food- and pharmaceutical-grade colour additives.  She has a broad experience of working not just in regulatory affairs, but also in production, quality control, administration, and research and development, including working in laboratories at the US FDA and in a clinical analytical laboratory setting.  Leslie is adaptable, proactive and effective in both independent and team work situations, and holds a Bachelor of Science in Biochemistry, and a Master of Science in Instrumental Analytical Chemistry.