Dana Nohynek, MSc, RAC

Director, Regulatory Affairs and Quality Assurance

Dana joined the CTN as a director of regulatory affairs and quality assurance in 2013. She leads the regulatory and quality affairs functions within the CTN through the management of infrastructure and guidelines for creating, maintaining and enhancing administrative, regulatory and quality assurance systems associated with conducting clinical trials. Dana has the overall responsibility for developing, facilitating and executing regulatory strategies to support CTN studies and to oversee the maintenance and compliance of quality systems.

Dana holds a BSc (Honors) from the University of Waterloo (1998), a MSc from the University of Toronto (2000) and a RAC certification (2006) granted by the Regulatory Affairs Professionals Society (RAPS). She has >10 years of industry experience that includes the development of regulatory strategies throughout various phases of clinical investigation, extensive interactions with regulatory authorities, preparation and submission of applications to health agencies in Canada, the United States and Europe. In addition, Dana has implemented quality systems, developed internal training programs, and participated in agency audits.

Dana has worked for small to mid-size biotech and medical device companies as well as with large pharma. She is an executive member of RAPS’s Southern BC chapter.