Sandra M. Ireland
MBA, B.Sc., RAC
Sandra is a certified Regulatory Affairs professional with a successful +20-year performance record in regulatory affairs, clinical affairs and quality operations at small, medium and large healthcare companies. She began her career working at Novartis and GlaxoSmithKline. Throughout her career, she has strategized cost-effective regulatory affairs management systems for drugs, natural health products, medical devices and cosmetics in Canada.
She has worked with local and global manufacturers, importers, distributors, third party logistics, supply chains, marketing departments and various regulatory agencies in Canada, the United States and Europe.
Her career highlights include managing the successful initiation of clinical trials and product launches in Canada, approvals of Health Canada drug submissions, reconsiderations requests, and hotlist exemptions. Sandra has also secured 100% compliance ratings for numerous Health Canada audits to support site licencing for NHPs, and establishment licencing for drugs and medical devices.
Sandra has been an industry speaker for quality and compliance courses at the Pharmaceutical Sciences Group (PSG) and the International Pharmaceutical Academy (IPA). She is an active member of these associations as well as a committee member of the Canadian Association of Pharmaceutical in Regulatory Affairs (CAPRA) and the Regulatory Affairs Professionals Society (RAPS). She received her B.Sc. in Biochemistry and Chemistry from the University of Western Ontario. She also holds a post degree certification in Pharmaceutical Regulatory Affairs & Quality Operations from Seneca College, a Clinical Research Associate Diploma from the Michener Institute in Toronto and a MBA from Athabasca University.