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 or 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. 

Program delivery options:

Fall Intake: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous online classes. A field experience occurs in Semester 3 and is in-person. This offering is unavailable to international students. 

Winter Intake: Courses are scheduled over two 14-week semesters, and classes are a mix of in-person at the International Graduate School campus, self-directed online modules and synchronous online classes. This offering is open to domestic and international students. 

Work-Integrated Learning

Having solidified your theoretical foundation in the first two semesters, the third semester becomes pivotal – the experiential component. Imagine putting theory into practice. Supported by industry expert faculty, you will transition your theoretical knowledge into practice, to work through real world situations to ensure that you are ready to be successful in the regulatory affairs field, head on! 

The format of experiential learning is determined by your selection of program delivery: Fully Online, or Hybrid (in-person and online courses).

Field Experience 

Students enrolled in the fully online delivery method will engage in 450 hours of field experience that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Field experiences are conducted in a wide range of organizations such as pharmaceutical, natural health products (NHP), medical device and biotechnology companies, as well as contract research organizations, hospitals, government agencies/departments, and scientific institutions. 

To progress into Semester 3, students must have successfully completed the first two semesters. During Semester 3, students complete their learning at field experience sites, and assessments are carried out by assigned supervisors at the field experience site. While Humber does assist students in finding their field experience by working with industry partners to identify openings, students are responsible for finding their own field experience that is aligned with learning outcomes of our program. 

Visit Future Students > Work-Integrated Learning > to learn more about your WIL power and other success stories. 

Also take time to explore the digital Faculty of Health Sciences & Wellness Student Handbook to learn foundational WIL concepts, plus requirements specific to this program.

Experiential Learning

Capstone Experience   

Students enrolled in the hybrid delivery method will engage in an immersive in-person capstone project supported by industry expert faculty. Working collaboratively, learners will engage with routine tasks, challenges and duties commonly seen within regulatory affairs. This hands-on, supported learning opportunity will provide learners with the tools, resources and portfolio to enter into the field of regulatory affairs with all the necessary skills for success. 

Regulatory affairs is a crucial field within industries such as pharmaceuticals, biotechnology, medical devices, cosmetics, food and chemicals. Professionals in regulatory affairs play a vital role in ensuring that products comply with regulatory requirements set by government agencies, thereby safeguarding public health and ensuring market access.  

Possible career opportunities include:  

• clinical regulatory affairs co-ordinator/specialist 
• government regulatory affairs officer 
• medical device regulatory specialist  
• pharmaceutical regulatory affairs scientist 
• regulatory affairs consultant/contractor  
• regulatory affairs specialist 
• regulatory affairs specialist/associate 
• regulatory affairs trainer/educator 

These are just a few examples of the diverse career paths available to Regulatory Affairs graduates. The field offers opportunities for growth, specialization and impact across various industries essential for public health and safety.