Regulatory Affairs

Whether you are starting your journey in the pharmaceutical, medical devices, food industries or other sectors with regulatory needs, Humber’s Regulatory Affairs graduate certificate program is designed to equip you with the skills for success. 

This program focuses on making regulatory affairs concepts accessible and applicable. You will uncover the regulatory system, legislation, procedures and practices relevant to developing, producing and marketing health-related and consumable products. 

We explore the significance of globally harmonized regulations and future industry trends by examining international and Canadian legislation, regulations, and guidelines. Throughout your studies, you will cover various standards and regulations including the GxP (Good X Practice) guidelines and regulations applied in different industries, particularly in sectors such as pharmaceuticals, health care, biotechnology, food and cosmetics.  

We will cover the steps for product submission, assembling documents and navigating product registration. And, we will delve into the intricacies of negotiation and follow-up, as well as connecting with federal and provincial formularies.  

Our program emphasizes the importance of teamwork and communication skills. Our aim is to help you cultivate these abilities, ensuring effective communication and adept data management tailored specifically to the field of regulatory affairs. 

This program is offered in two formats,

1. Online - open to domestic students only. Courses are scheduled over two 14-week semesters, and are a blend of self-directed online modules and synchronous online classes. Includes work-integrated learning; field experience.
2. Hybrid - open to both domestic and international students. Courses are scheduled over two 14-week semesters, and classes are a mix of in-person, self-directed online modules and synchronous online classes. Includes experiential learning; capstone experience.