Regulatory Affairs
Make September 2025 your time to shine. Apply on us and get your $150 application fee back*. See details.
Program Overview
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.
Courses
At Humber, courses are delivered in a variety of formats:
In-Person - An in-person course is delivered fully on campus.
Online Asynchronous (A) - An online asynchronous course has no fixed class schedule and allows students to engage with the course at different times according to their needs. Faculty provide modules, which are completed independently by the students according to established deadlines.
Online Synchronous (S) - An online synchronous course is delivered fully online and requires faculty and students to participate in real-time according to a fixed schedule. Classes are scheduled for a specific day and time.
Hybrid - A hybrid course is a combination of in-person and online classes and follows a set schedule. Students must be available to attend in-person classes at scheduled times during the semester.
The chart below outlines the delivery options available for each course in this program, by campus. For some academic terms, there may be more than one delivery option available. You’ll be able to select your preferred options when building your course schedule during open enrolment. Preferences for course delivery will be considered on a first come, first served basis. Some Humber programs are also delivered fully online, where all courses are delivered online.
International students: the impact of studying from outside of Canada on Post-Graduation Work Permit (PGWP) eligibility differs significantly based on when you start your program. Please review the PGWP eligibility before choosing your program and course delivery.
| Course code and Name | Delivery Type by Location | ||||
|---|---|---|---|---|---|
| Course Code | Course Name | North | Lakeshore | IGS | DL/Online |
| Semester 1 | |||||
| RARC 5000 | Regulatory Communications & Ethical Practice | Online (S) | N/A | N/A | N/A |
| RARC 5001 | Health Legislation, Regulations and Guidelines | Online (S) | N/A | N/A | N/A |
| REGA 5022 | Product Development - CMC | N/A | N/A | N/A | Online (S) |
| REGA 5023 | Post Market Surveillance | N/A | N/A | N/A | Online (S) |
| REGA 5025 | Drug Product Lifecycle | N/A | N/A | N/A | Online (S) |
| Semester 2 | |||||
| RARC 5500 | Regulatory Projects on Emerging Trends | Online (S) | N/A | N/A | N/A |
| REGA 5021 | Product Development-Premarket | N/A | N/A | N/A | Online (S) |
| REGA 5034 | Medical Devices | N/A | N/A | N/A | Online (S) |
| REGA 5035 | Provincial Formularies and Reimbursement Policy | N/A | N/A | N/A | Online (S) |
| REGA 5037 | Management of Regulatory Submissions | N/A | N/A | N/A | Online (S) |
| REGA 5041 | Professional Preparation - Regulatory Affairs | N/A | N/A | N/A | Online (S) |
| Semester 3 | |||||
| REGA 5040 | Field Experience - Regulatory Affairs | N/A | N/A | N/A | Online (A) Online (S) |
Work-Integrated Learning
Following two academic course-based semesters, students complete a three-month (450 hours) 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 site of the field experience. 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.
An Education in High Demand
Exciting developments are happening in the medical, pharmaceutical, food, and natural products industries all the time! Our society's strong focus on health, wellness, safety, and effectiveness means there is a lot of attention on safely creating new interventions, supplements, and drugs. Plus, we are always working to enhance overall health and well-being. At Humber, we provide comprehensive education and skill development that makes you marketable when combined with your work experience and previous degrees. Join us and be part of this dynamic field where your skills can make a real difference!
In the Industry
Regulatory Affairs professionals are dedicated to safeguarding public health while ensuring the safety and effectiveness of various products. This profession was born out of governments' commitment to protecting public health and the responsibility of companies to provide safe products that positively impact public health and well-being.
In response to this need, a new class of professionals emerged to navigate the intricate regulatory landscape and ensure that companies meet the necessary standards for product discovery, testing, manufacturing, and marketing. Join us in this dynamic field where you can make a meaningful difference in public health while contributing to the safety and welfare of communities worldwide.
The Humber Advantage
Student-Centric Program Design and Industry Expertise
Ready to dive into the world of Regulatory Affairs? At Humber, our program is expertly crafted for your success! In the first two semesters, you will experience a strategic blend of theory and practice, setting a solid foundation for your learning. You will have opportunities to put theory into practice with tools commonly used in industry.
But it does not stop there! In the third semester, prepare for hands-on action with a 450-hour internship, where you will apply what you learned in real-world scenarios.
Throughout this comprehensive one-year program, you will not only learn but also develop and reinforce essential skills, preparing you to step confidently into the workforce upon graduation.
The Humber Experience
The Right Fit
Is this the right path for you? If you thrive on policies and guidelines, are self-motivated, enjoy teamwork and problem-solving, then the Regulatory Affairs program could be your perfect fit! Join us and embark on an exciting career journey where you can make a meaningful impact.
Testimonials
Interested in Regulatory Affairs at Humber College yet want to know more before enrolling?
Your Career
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.
Program Availability
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Jan 2025 | IGS | Open |
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Sep 2025 | Online | Online | Open |
| Jan 2026 | Course-Based | IGS | Open |
Domestic students can now apply to this program at Humber’s new International Graduate School (IGS).
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Jan 2025 | IGS | Open |
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Sep 2025 | Online | Online | Not Available |
| Jan 2026 | Course-Based | IGS | Opening Soon |
International students can now apply to this program at Humber’s new International Graduate School (IGS).
Humber is a publicly-funded institution and does not have a public-private partnership. International students graduating from Humber or Humber’s International Graduate School (IGS) are eligible to apply for a Post-Graduation Work Permit.
International Students in Canada who apply for September 2024 start could be eligible for an automatic scholarship*. Apply now
Please note the new International Admissions Process and Provincial Attestation Letters. Read the update
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Jan 2025 | IGS | Open |
| START | DELIVERY | LOCATION | STATUS |
|---|---|---|---|
| Sep 2025 | Online | Online | Not Available |
| Jan 2026 | Course-Based | IGS | Opening Soon |
International students can now apply to this program at Humber’s new International Graduate School (IGS).
Humber is a publicly-funded institution and does not have a public-private partnership. International students graduating from Humber or Humber’s International Graduate School (IGS) are eligible to apply for a Post-Graduation Work Permit.
International Students Out of Canada can Apply through Humber International
Please note the new International Admissions Process and Provincial Attestation Letters. Read the update
Upcoming Recruitment Events
News Feed
IPE Blackboard Site
Wed, December 20, 2023
The Faculty of Health Sciences & Wellness is launching a new tutorial Blackboard site entirely dedicated to IPE!
Navigating Health Care
Thu, September 28, 2023
Humber’s North Campus was proud to host The Central West Navigation Conference on Tues Sep 26.
Humber Launching Student Led Hearing Clinic
Mon, August 21, 2023
A multi-service clinic servicing the Humber community and area.
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