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Regulatory Affairs

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Program Code: 07721
Credential: Ontario Graduate Certificate
Start Dates: September
Program Length: 3 semesters
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Humber is proud to have the highest graduate employment and employer satisfaction rate of the GTA colleges based on Colleges Ontario’s key performance indicators for college graduates in 2022-2023.

Program Overview

Humber’s Regulatory Affairs graduate certificate program equips graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This online program focuses on developing the concepts, skills, and techniques required to work in regulatory affairs in the pharmaceutical, health products, medical devices, biotechnology industries, food industries and other sectors that require a regulatory component. You will gain knowledge of the regulatory system, legislation, procedures and practices that relate to the development, manufacture, quality assurance, and marketing of health-related and consumable products. 

The importance of internationally harmonized regulations and future trends in the industry is examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), good documentation practices (GDP), the International Organization for Standardization (ISO), the Canadian Food and Drugs Act (CFDA), the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines.

Teamwork and communication skills are reinforced throughout the program, and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; assembling documents and statistical evidence; the complexity of product registration, negotiation, and follow-up; and linking the federal government and provincial formularies.

Program Delivery: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous remote classes. A field experience occurs in Semester 3 and is in-person.

This program is not available to international applicants.

Courses Open "Courses" to view individual course delivery modes.

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 online 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.

paramedic students holding a gurney with a training dummy on it

Watch the video to learn what is work-integrated learning.

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.

Compliance Rules Law Regulation Policy Business Technology concept.

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

Our graduates typically pursue careers in the regulatory affairs departments in pharmaceutical, medical devices, biotechnology, consulting, inspection and quality assurance agencies, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.

Program Availability

Start dates between Sept 2024 - Aug 2025
START DELIVERY LOCATION STATUS
Sep 2024 Online Online Open
Start dates between Sept 2024 - Aug 2025
START DELIVERY LOCATION STATUS
Sep 2024 Online Online Not Available

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 dates between Sept 2024 - Aug 2025
START DELIVERY LOCATION STATUS
Sep 2024 Online Online Not Available

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

Recruitment Events

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Every attempt is made to ensure that information contained on this website is current and accurate. Humber reserves the right to correct any error or omission, modify or cancel any course, program, fee, timetable or campus location at any time without prior notice or liability to users or any other Person.

GET YOUR $125 APPLICATION FEE BACK*

Apply On Us This September!

Apply through OCAS between June 14 - July 19, 2024 and be registered full-time on Tuesday, September 17, 2024 and receive a $125 credit equal to the domestic application fee.

To qualify, get started by filling out the APPLY ON US form.

*This promotion is open to domestic applications for the September 2024 program intakes only. Offer not valid for existing applicants or applications.

International Students with a valid Study Permit or Letter of Introduction (LOI)* can receive a Waiver Code to cover the $100 September 2024 application fee.

Bringing You Our A-Game

A Humber education is second to none, benefit from:

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How to Apply

Domestic Students

Applications to Humber are made through ontariocolleges.ca. Be sure to submit your application by July 15, 2024 to receive your Application Fee Credit. Applications for September will remain open as long as the program availability status shows Open.

To check program availability refer to the Campus/Availability listing on Humber’s program pages, search by availability, or ontariocolleges.ca.

To see where you are in the admissions process, visit the Admissions Road Map.

International Students

If you’re an international student, you can apply directly to Humber via our International Centre.

Contact Us

Admissions Questions

General Enquiries

Call 416-675-3111 or email enquiry@humber.ca. If you have already applied, be sure to check your application status on myhumber.ca.

Domestic Applicants Enquiries

Domestic applicants can book a one-on-one advising appointment with an admissions representative.

International Applicants Enquiries

Contact the International Centre for information about full-time programs (including the International Graduate School), how to apply and to follow up on your submitted application.

Program-Specific Questions

Speak to the Program Co-ordinator about the course curriculum, projects and career options.

Shyam Mohamed

, program co-ordinator
416.675.6622 ext. 4566
shyam.mohamed@humber.ca

Campus Information

Book a campus tour to take a closer look at what it's like to be a student at Humber.

Want More Info?

Find out more about the student experience and everything that Humber has to offer Future Students.

for more info on Humber, including programs, special events and more!

How To Become An Apprentice

Becoming an Apprentice

Find an employer willing to sponsor you as an apprentice.

Contact the Ministry of Labour, Immigration, Training and Skills Development to register as an apprentice.

Work with your employer approximately one year before attending Humber.

View Instructions 

Ontario Youth Apprenticeship Program (OYAP)

If you’re in high school – grade 11 or 12 – you can earn co-op education credits through work placements in some skilled trades.

Visit OYAP 

How to Apply

Domestic Students

Applications to Humber are made through ontariocolleges.ca. Be sure to submit your application by the equal consideration deadline of February 1. You may apply after February 1, however, post-February 1 applications will be considered on a first-come, first-served basis depending on the availability of the space in the program.

To check program availability refer to the Campus/Availability listing on Humber’s program pages, search by availability, or ontariocolleges.ca.

To see where you are in the admissions process, visit the Admissions Road Map.

International Students

If you’re an international student, you can apply directly to Humber via our International Centre.

Need Advice?

Program Advising Appointments

Get help narrowing down your program options or book a one-on-one pre-enrolment advising appointment with one of our Recruitment Officers.

Transfer & Pathway Advising

Book a virtual appointment with a Student Mobility Advisor learn more about getting Transfer Credit(s) for previous post-secondary experience, Prior Learning Assessment and Recognition (PLAR), and Pathways options.

Admission Requirements

Admission selection is based on the academic criteria indicated. Meeting minimum eligibility requirements does not guarantee admission.

Admission selection is based on the following three requirements:

  • Academic

    To be eligible for admission, you must possess the following:

    • A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field.

    Mature Applicants

    Diplomas and Certificates

    An applicant is considered a mature applicant if they have not completed secondary school or other postsecondary school, and will be 19 or older as of the first day of classes. Humber will invite you for testing to demonstrate that you meet all listed course requirements.

    Degrees

    An applicant is considered a mature applicant if they have not completed secondary school or attended postsecondary studies, and will be 21 or older as of the first day of classes. Mature applicants for degree programs will be required to meet course requirements at the U/M level or equivalent.

    College Transfer Applicants

    Diplomas and Certificates

    An applicant is considered a college transfer applicant if they have completed some or all of a college-level credential. Humber may use a combination of secondary school and/or college courses and grades to determine program eligibility.

    Degrees

    An applicant is considered a college transfer applicant if they have completed some or all of a college-level credential. Humber may use a combination of secondary school and/or college courses and grades to determine program eligibility. Applicants must have an overall minimum grade point average (GPA) of 65 per cent in the program. Applicants are required to disclose and provide academic transcripts for all course work completed at the postsecondary level.

    University Transfer Applicants

    Diplomas and Certificates

    An applicant is considered a university transfer applicant if they have completed some or all of a university-level credential. Humber may use a combination of secondary school and/or university courses and grades to determine program eligibility.

    Degrees

    An applicant is considered a university transfer applicant if they have completed some or all of a university-level credential. Humber may use a combination of secondary school and/or university courses and grades to determine program eligibility. Applicants are required to disclose and provide academic transcripts for all course work completed at the postsecondary level.

  • English Language Proficiency

    All applicants whose first language is not English must meet Humber’s English Language Proficiency Policy.

  • International Credit Evaluation

    Canadian citizens or permanent residents with international education are required to provide a credential evaluation. Note, for international High school education course by course evaluations, ICAS must be used. For international post-secondary education, a WES evaluation must be provided. In situations where you expect to apply for transfer credit, it is recommended that a course by course WES evaluation is completed.

    Please note: A WES course by course evaluation is required for this program.

International Academic Equivalency

Admission equivalencies for Humber depend on your country of study. Please enter your location or choose detect my location to see the requirements for your country below.

Post-Admission Requirements

Once you have been accepted, and have confirmed your offer, you may need to complete a further set of requirements related to your program (Post-Admission Requirements).

N/A

Equipment & Device Requirements

Semester 1

Details and Specifications Minimum Specifications Recommended Specifications
Processor Intel i5-8300H (PC)
4-core or higher 64bit (Mac)
Intel i5-8300H (PC)
4-core or higher 64bit (Mac)
OS Windows 10 (PC)
OS 10.15 (Mac)
Windows 10 (PC)
OS 10.15 (Mac)
Memory 8GB of RAM 8GB of RAM
Storage 256GB 256GB
Monitor Laptop Laptop
Other Built-in microphone and webcam, Software: Adobe creative and Microsoft office Suite Built-in microphone and webcam, Software: Adobe creative and Microsoft office Suite

Program-Specific Questions

Speak to the Program Co-ordinator about the course curriculum, projects and career options.

Shyam Mohamed

, program co-ordinator
416.675.6622 ext. 4566
shyam.mohamed@humber.ca

Fees & Financial Aid

The 2024/2025 fee for three semesters is:

  • domestic: $7,501.08
  • international: $28,183.32

Fees are subject to change.

Fees by Semester

Domestic Fees International Fees

Financial Aid, Scholarships and Bursaries

Understand the costs associated with coming to Humber and explore resources available from first year to your final year on Student Fees and Financial Resources.

Scholarships

Humber Scholarships

Find out more about scholarships and bursaries that you may be eligible for, visit Student Scholarships. International students can visit International Student Scholarships.

Humber Bursaries

Bursaries are available for Certificate, Diploma and Degree programs primarily based on financial need, visit Humber Bursaries.

External Awards, Bursaries & Scholarships

Find out more information about external scholarships and bursaries, visit External Awards.

Indigenous Student Awards, Bursaries & Scholarships

Humber offers a variety of bursaries and scholarships for Indigenous students, visit Indigenous Student Awards.

Explore Opportunities through Humber Pathways

Humber Pathways include:

  • Opportunities to build on your college education and complete your diploma or degree at Humber.
  • Degree and graduate study opportunities at other institutions in Ontario, Canada and abroad.
View Pathways Into This Program  
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