Director Of Regulatory Affairs & Quality Assurance, M.SC., RAC
Ms. Nohynek joined the CIHR Canadian HIV Trials Network (CTN) at CHÉOS as Director of Regulatory Affairs and Quality Assurance in December 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.
Ms. Nohynek has the overall responsibility of developing, facilitating and executing regulatory strategies to support Network studies and to oversee the maintenance and compliance of quality systems.
She holds a B.Sc. (honours) from the University of Waterloo (1998), a M.Sc. from the University of Toronto (2000), and a RAC certification (2006) granted by the Regulatory Affairs Professionals Society (RAPS). She has more than ten years of industry experience that includes the development of regulatory strategies throughout various phases of clinical investigation, extensive interactions with regulatory authorities, and preparation and submission of applications to health agencies in Canada, the United States, and Europe. In addition, she has implemented and maintained quality systems, prepared for and participated in agency audits, and developed internal training programs.
Ms. Nohynek 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’ Southern B.C. chapter and a professional member of the Canadian Association of Professionals in Regulatory Affairs.