The program entails an intensive series of learning modules developed to enable a practical understanding of the regulatory approval and communication processes involving pharmaceutical and biotechnology drugs as well as natural health products and medical devices. While the primary emphasis is on regulatory affairs as it applies in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drugs Administration (FDA), the regulations in other major jurisdictions such as Europe, Japan and Australia will also be covered. You will acquire knowledge of international health care system, health care legislation, procedures and practices for regulating the development, manufacture, quality assurance and marketing of health care products.

In this program, you will learn and acquire specialized knowledge and practical skills required to function as a Pharmaceutical Regulatory Affairs professional in the pharmaceutical, biotechnology, medical devices, food, cosmetics, natural product, nutraceutical and other life-science industries. Pharmaceutical Regulatory Affairs professionals responsible for developing, compiling, and filing documentation required to support the licensing and approval of pharmaceutical drugs. They are involved in active liaison with regulatory authorities such as the Canadian Therapeutic Products Directorate (TPD) and the US Food and Drugs Administration (FDA). The success of the Company is invariably dependent on the accuracy and efficiency of drug submissions Graduates of this program enjoy a high percentage employment rate and work for both multinational and generic company employers such as GSK, Apotex, Biovail, Teva, Patheon, Novopharm, AstraZeneca, Pharmascience, Amgen, and Taro pharmaceuticals. They also find employment in biopharmaceutical, biotechnology and advanced-drug delivery companies.