Dana Nohynek, MSc., RAC is a regulatory and clinical consultant that works with start-up and clinical stage biotech organizations to advance therapeutic and medical device programs through the development pathway to market approval. Her expertise includes regulatory strategy development and tactical execution, liaising with regulatory agencies during product development and through the marketing submission, clinical development planning, and providing regulatory perspectives for corporate strategic planning.
Prior to consulting, Dana has worked for small to mid-size biotech and medical device companies as well as with large pharma. Her industry experience includes the development of regulatory strategies throughout various phases of clinical investigation, extensive interactions with regulatory authorities, and submissions to health agencies in the United States, Canada and Europe. In addition, she has implemented and maintained quality systems, prepared for and participated in agency audits, and developed internal training programs.
Dana is also the Director of Regulatory Affairs & Quality Assurance at the CIHR Canadian HIV Trials Network. She has the overall responsibility of developing regulatory strategies to support Network studies and to oversee the maintenance and compliance of quality systems.
Dana holds a B.Sc. (honours) from the University of Waterloo, a M.Sc. from the University of Toronto, and a RAC certification granted by the Regulatory Affairs Professionals Society (RAPS). She is an advisory board member to select companies and a past executive member of RAPS’ Southern B.C. chapter.
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