Dr James Swales
Dr Swales is a physician with medical affairs, regulatory, clinical development and medical experience. He trained at St. George’s Hospital Medical School, obtaining his MB BS in 2001. He worked as a doctor in the NHS in various specialities until 2007 before leaving to join the pharmaceutical industry.
He joined Novartis and gained experience of clinical development of inhaled respiratory medicines, including the design and running of clinical trials, interactions with KOLs and the production of regulatory submission documents for a successful EMA centralised application. Proven ability to work to tight deadlines, work on multiple complex tasks and produce work to a high quality.
He gained regulatory experience as a medical assessor at the Medicines and Healthcare Devices Regulatory Agency in a busy team with wide ranging responsibilities. Experience in many therapeutic areas including respiratory, gastrointestinal & nutrition, blood, pain, oncology and dermatology. Regulatory experience includes EMA centralised assessments, new chemical entities, orphan products, regulatory advice, production of guidelines and reflection papers and over the counter medicines reclassification.
As Director of Clinical Innovation at Johnson and Johnson Consumer Health he was the Medical Affairs lead with clinical and innovation responsibilities, looking after the Digestive Health portfolio globally including products such as Imodium, Motilium and Microlax. The role required close working with R&D and Marketing colleagues on current products both for lifecycle management and innovation and new product development. This included not only traditional small molecule medicines but also medical devices, probiotics, naturals and apps.