Stephanie Anderson Email and Phone Number

I have over a decade regulatory experience in the pharmaceutical industry. I work in all phases of development including authoring, development, and driving strategy for PRIME, Fast Track, and Breakthrough requests, CTAs and INDs, orphan medicinal product designations, paediatric investigational plans (PIPs) and initial pediatric study plans (iPSPs), scientific advice, pre-submission meetings, accelerated assessment requests, and Marketing Authorisation Applications (MAAs), New Drug Submissions (NDSs) and New Drug Applications (NDAs). I act as a product manager to maintain and to expand marketing authorisations and to harmonize global labeling. I have acted as the Regulatory Lead for a number Early Access Programs (Named Patient Programs and Compassionate Use Programs) and for interventional and non-interventional/observational clinical trials (Phase I-IV). I've been responsible for managing regulatory disclosures on ClinicalTrials.gov and EudraCT.In 2018, I was a panelist in the Latin America Legislator's Forum at the RAPS Regulatory Convergence in Vancouver, Canada, I presented at the AMEPRES 3rd Annual International Summit in Cancun, Mexico, and I presented at the ICON Workshop on Success in Rare Disease Drug Development in South San Francisco, United States. In 2013, I was a Career Day Panelist representing regulatory affairs for the Life Sciences Career Development Society (University of Toronto). In 2011 and 2012 I was an invited speaker at the University of Waterloo, my alma mater, on the topic of regulatory affairs. In 2011, I authored a chapter on Product Classification in the Fundamentals of Canadian Regulatory Affairs published by RAPS. I have a Master’s degree in Biochemistry and Physiology from the University of Western Ontario and a Post-Graduate certificate in Regulatory Affairs from Humber College.