Jan Sedgeworth, Ph.D.
Jan has 25 years of experience in the pharmaceutical and biotechnology industry, during which time she has worked as a senior management level person in large pharmaceutical corporations, small biotechnology companies, and has owned and operated a consulting firm. Throughout her career she has been recognized by peers and clients for her ability to establish strategies, execute plans within target timeframes and budgets, make decisions, and cultivate relationships with regulators. Jan’s pharmaceutical industry more than eight years as the head of Regulatory Affairs and Quality Operations at SmithKline Beecham Canada (subsequently GlaxoSmithKline). During that time, she was operationally responsible for building an effective and highly motivated team of 25 professionals and was responsible for the approval of more than 18 pharmaceutical and biological New Chemical Entities.
Her biotechnology experience included the position of Vice President of Global Regulatory Affairs at Hemosol Inc., where she was responsible for the on time filing of the UK marketing application for the company’s lead product, and working with FDA to navigate some difficult regulatory challenges. Dr. Sedgeworth also established her own consulting firm in 2003, offering services to established pharmaceutical companies, emerging biotechnology companies and contract research organizations. Carexa Inc. was acquired by Intrinsik Inc., in 2010. Jan’s offers specialized knowledge of the regulatory environment in North America and broad-based knowledge of global regulatory processes, including direct experience and long standing established relationships with Health Canada and FDA. Her experience covers a number of therapeutic areas including CNS, cardiovascular, diabetes, oncology, and different product types such as blood products, vaccines and small molecules.
- Regulatory strategy for pharmaceutical and biotechnology products
- Preparation of regulatory dossiers for 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. (Hons), Chemistry, University of Strathclyde, United Kingdom