Julia Chan

Associate Director, Regulatory Affairs

Mississauga, Ontario

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Phone: 1-905-364-7800
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Associate Director, Regulatory Affairs

Julia Chan is an Associate Director of Regulatory Affairs at Intrinsik Corp.  She has been a regulatory affairs professional within the biotechnology industry for over 20 years, in both industry and consulting. Julia’s regulatory strategy, authoring support and submission management experience has been primarily for products in Canada and US, in both development and post approval. Her experience includes critical assessment of data and scientific documents in conjunction with applicable regulations and client business needs. Regulatory authority interactions, including Sponsor meetings, have also covered North America, associated with various stages of development and submission types (CTA, IND, NDS and NDA). Julia is a member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and the Regulatory Affairs Professionals Society (RAPS).

Experience Highlights

• Review, preparation, authoring support and filing of regulatory submissions, including for pre-submission meetings.
• Regulatory affairs strategy development and execution.
• Compliance with applicable regulations and guidelines (CTA, IND, NDS and NDA).
• 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

• Regulatory Affairs Certification (RAC) U.S. (accredited 2008)
• B.Sc. (Joint Honours), Pharmacology and Physiology, University of Leeds, England

Professional Affiliations

• Canadian Association of Professionals in Regulatory Affairs

• Regulatory Affairs Professionals Society