Julia Chan

Associate Director, Regulatory Affairs

Mississauga, Ontario

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Phone: 1-905-364-4830
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Julia Chan is an Associate Director of Regulatory Affairs at Intrinsik Corp. She is a regulatory affairs professional with over 20 years of experience in the biotechnology industry, spanning both industry and consulting roles. She has expertise in regulatory strategy, as well as the authoring and management of submissions for products across Canada and the United States, covering both development and post-approval phases. Julia’s experience includes the critical assessment of scientific data and documentation in conjunction with regulatory requirements and client business objectives. She has also led and supported interactions with regulatory authorities across North America, including sponsor meetings, at various stages of product development and across multiple 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

Join Our Team

Intrinsik Corp., is a dynamic science-based consulting firm. We are eagerly interested in professionals to add to our accredited staff base. Intrinsik is strongly committed to our employees by ensuring mentoring, training and advancement for those with a drive to succeed. Our areas of expertise include and are not limited to toxicology, human health and environmental risk assessment, biology, multi-media exposure modeling, environmental science, and risk management.

Diversity is not only part of our company’s culture, it is a core business strategy. We are building a workforce that is representative of our society, and our programs and policies are designed to foster diversity and inclusion.

AODA Declaration
Our goal is to create an environment that is inclusive to all members of the community. Intrinsik Corp., focuses on identifying, removing, and preventing barriers for persons with disabilities, and our policy complies with the Accessibility for Ontarians with Disabilities Act, 2005 (AODA).