James Prasad

Biography

  Started my career in the pharmaceutical industry working as a R&D analyst/Validation analyst at the Douglas Pharmaceuticals. Following this I worked as an evaluator at Medsafe for 5 years with 3 and a half years in OTC evaluation and 1 and a half years in prescription medicine evaluation. In Australia I have worked as a regulatory consultant at Regulatory Concepts Pty Ltd, regulatory affairs associate at sanofi-aventis australia pty ltd (contractor) and senior regulatory affairs associate at Phebra Pty Ltd and MSD Australia. I am currently working as a senior regulatory affairs associate as Galderma Australia. Over the years I have worked on the registration and regulation of prescription, OTC, medical devices and cosmetics and have working expertise in all these areas. However, my particular strength is prescription regulatory affairs. My goal is to learn as much as I can about regulatory and clinical aspects of my job and use my expertise to contribute to the success of my employer and collegues. Specialties: Compliation, submission and maintainance of prescription and OTC dossier registrations in Australia and New Zealand. Listing of sunscreens and complementary medicines on the ARTG. Registration, conformity assessment renewals and variations of Class III medical devices in Australia. Regulation of cosmetics in Australia and New Zealand. Generating regulatory submission from scratch. Liasing with the varies committees and regulators as necessary. Problem solving. Critical assessment and evaluation of submissions. Project management of regulatory submissions Coaching and development of direct reports and people management Regulatory strategy  

Research Interest

  pharmaceutical sciences