Emma Cy Y.

WORK HISTORY

EDUCATION

SKILLS

ABOUT EMMA CY Y.

Emma Yuen has 15+ years of expertise in the life sciences sector, including 8+ years in Drug Development, as well as 7 years in Genomics, across North America, Europe and Asia-Pacific, in global top 10 large CRO, award winners mid-sized CROs, Canada\'s top hospital-based research institute, renowned consulting and non-profit environments. Expert in Regulatory Affairs and Clinical Research (Clinical Pharmacology, Ethics & Regulatory Affairs, Regulatory Intelligence/Strategy/Writing, Site Activation/Feasibility) roles of increasing leadership, Emma has contributed to 200+ studies, bioequivalence/phase I to studies, in diverse therapeutic areas, including neuroscience, oncology, rare diseases, cardiometabolic, as well as leading submissions to key global Regulatory Agencies/Ethics Committees across multicultural teams, along with strong knowledge/experience of Canadian/US regulatory guidelines on clinical, manufacturing and commercialization of pharmaceutical drugs, biologics and medical devices. She currently act as Regulatory Affairs Manager at Worldwide Clinical Trials for 2+ years. Emma is a founding member of Regulatory Affairs Professionals Society (RAPS) Quebec Local Networking Group (LNG) and Regulatory Affairs Toastmasters (RAT), a member of Canadian Association of Professionals in Regulatory Affairs and Asia Regulatory Professionals Association. She is serving on the Leadership Team-Vice Co-Chair of the RAPS Quebec LNG and Steering Committee-Vice Chair Programs of Women In Bio Greater Montreal Chapter. She is the immediate past Club Officer-Secretary of RAT and Toastmasters Leadership Club. Emma supports graduates students\' career transition from academia to the industry. She has mentored individuals to elevate their career growth at RAPS Convergence 2024, moderated roundtable discussions at the Desjardins Centre for Advanced Training \"Career Spark Networking Event\" and at the Talent InVivo “Careers in Health: From Drug Discovery to Commercialization” event, as well as served as a panelist at the Women In Bio, in collaboration with Montreal InVivo,\"From Research to Industry: Expanding Career Horizons in Life Sciences\" event in 2025. Emma holds a Master\'s in Pharmaceutical Sciences and a Specialized Graduate Diploma in Drug Development, Regulatory Affairs, from the University of Montreal, Honours Bachelor\'s in Biopharmaceutical Sciences, Genomics, from the University of Ottawa, Certified Associate in Project Management from the Project Management Institute and Certified Clinical Research Associate from Kriger Research Group International.