Stephanie Anderson

Associate Director, Regulatory Affairs

Mississauga, Ontario

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Phone: +1 343-961-6164
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Stephanie Anderson is an Associate Director of Regulatory Affairs at Intrinsik Corp.  She has been a regulatory affairs professional within the pharmaceutical/biotechnology industry since 2010. Stephanie has been involved in a broad range of regulatory activities from clinical development to post-registration license maintenance. Her experience includes authoring, review, and submission of CTAs, INDs, NDSs, NDAs, and MAAs to Health Canada, FDA, and the within the EU through Decentralised and Centralised Procedures. She has also provided strategy for and participated in regulatory authority interactions with Health Canada, FDA, EMA (CHMP, COMP, PDCO), BfArM, and MHRA. Stephanie is a member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and the Regulatory Affairs Professionals Society (RAPS). She has contributed to pharmaceutical industry workshops, been an invited speaker on the topic of regulatory affairs, and has authored a chapter for the Fundamentals of Canadian Regulatory Affairs.

Experience Highlights

• Regulatory affairs strategy development and execution.
• Preparation of gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
• Management, preparation, review and filing of regulatory documents and submissions in compliance with applicable regulatory guidelines for the United States, Canada, EU, and MHRA.
• Oversight of submission quality, timelines and budgets for a range of clients, managing necessary cross-functional resources.
• Regulatory Authority and client interactions for efficient regulatory submission development.

Education and Professional Qualifications

• M.Sc., Biochemistry and Physiology, University of Western Ontario
• Regulatory Affairs Post-Graduate Certificate, Humber College
• B.Sc. (Honours), Molecular Biology and Biotechnology, University of Waterloo

Professional Affiliations

• Canadian Association of Professionals in Regulatory Affairs
• Regulatory Affairs Professionals Society