Lesley is an accomplished leader with more than 24 years’ experience in R & D roles within the pharmaceutical industry. She has led teams of up to 75 staff across Asia Pacific, the US and Europe working to secure the approval of new therapies in a highly regulated environment. In this time Lesley has worked on a wide range of therapeutic areas and dosages forms including parenteral and inhalation products, generics and biosimilars.
Lesley is uniquely positioned in Australia as a senior Regulatory Affairs expert with knowledge and experience of both the local regulatory environment, as well as all of the major markets globally (US, EU, Canada, Middle East, Japan & Asia). Lesley’s specific expertise is in developing regulatory dossiers for new products from the ground up, where an intimate knowledge of pharmaceutical development principles and regulations is required. As well as hands on dossier preparation, Lesley can assist clients with the development of regulatory strategies and the setup of regulatory systems and processes.
Since 2014 Lesley has acted as an external evaluator for the Australian Therapeutic Goods Administration (TGA) where she is responsible for the assessment of the quality aspects of new medicines. Lesley’s experience makes her uniquely positioned to provide clients with advice from the perspectives of both industry and the regulator.