Julia Chan

Associate Director, Regulatory Affairs

Mississauga, Ontario

Email: moc.k1623581965isnir1623581965tni@n1623581965ahcj1623581965
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

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).

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us