I have a Master’s Degree in Medical Science (drug development) and currently work for Specialised Therapeutics Australia. I have worked in the pharmaceutical industry since 1983, commencing my career within the toxicology group of Glaxo UK, working on the development of NCE's. Since 1992 I have been working as a regulatory affairs professional with several Australian (Glaxo Australia, Faulding, Institute of Drug Technology, Orphan Australia) and International (Abraxis BioScience) companies.My regulatory experience spans NCE’s, generic products, OTCs and devices, including orphan and niche drugs, covering a variety of dosage forms, ranging from early-stage development through to commercial product registration in a wide range of marketing applications submitted to various regional Health Authorities (USA, Canada, UK/EEC, Australia, New Zealand, and parts of Asia). In a previous role, I was responsible for the project management of a 5-year NIH-funded, Australian-based project to investigate a vaccine strategy for HIV/AIDS prevention, including the assignment and oversight of consultants performing animal toxicology studies and early phase clinical trials.In recent times, I have been responsible for regulatory approval strategies to ensure that new products are accessible to the Australian, New Zealand and South-East Asian markets in a timely manner. Working with international partners in a variety of therapeutic areas to help get their products to market has been a rewarding experience.