Jan Sedgeworth

Vice President, Regulatory Affairs

Mississauga, Ontario

Email: moc.k1582826747isnir1582826747tni@h1582826747trowe1582826747gdesj1582826747
Phone: +1 905-364-7800
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Dr. Jan Sedgeworth is a Vice President of Regulatory Affairs at Intrinsik Corp., and has more than 25 years of experience in the pharma and biotech industry, during which time she has worked at a senior management/executive level, and has owned and operated a consulting firm.  Her experience includes more than 9 years as the head of Regulatory Affairs and Quality Operations at SmithKline Beecham Canada (subsequently GlaxoSmithKline), and three years at Hemosol leading the international regulatory affairs function. Dr. Sedgeworth established her own consulting firm Carexa Inc. in 2003, providing regulatory services to pharma/biotech companies and contract research organizations. Carexa Inc., was acquired by Intrinsik Inc., in 2010, and Dr. Sedgeworth now leads the growing regulatory affairs function at Intrinsik Corp.  She offers specialized knowledge of the regulatory environment in North America and broad-based knowledge of global regulatory processes, including direct experience and established relationships with Health Canada and the US Food and Drug Administration (FDA).  Her experience covers a broad range of therapeutic areas and product classes, as well as registration strategies for orphan drugs, expedited approval (accelerated approval, conditional approval) and 505(b)(2) NDAs.

Experience Highlights

  • Regulatory strategy for pharmaceutical and biotechnology products.
  • Preparation of regulatory dossiers to conduct clinical research and for commercialization of drug products.
  • Regulatory problem solving and issue resolution.

Education and Professional Qualifications

  • AHFMR Post-doctoral Fellowship, Department of Chemistry, University of Alberta
  • Ph.D. Chemistry, University of Strathclyde, United Kingdom
  • B.Sc. (Honours), Chemistry, University of Strathclyde, United Kingdom

Professional Affiliations

  • Canadian Association of Professionals in Regulatory Affairs
  • Drug Information Association
  • Pharmaceutical Sciences Group
  • 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