Regulatory Affairs
Ontario Graduate Certificate
Program Code: 07721
Campus: Online
Length: 3 semesters starting in September
Regulatory affairs (RA) professionals are an integral part of protecting the public health. RA professionals are involved in controlling the safety and efficacy of food and health-related products by shepherding these products from conception to federal approval and public availability. Graduates of our program find work as RA specialists in a variety of fields such as:
- agrichemicals
- biotechnology
- hospitals
- medical device development
- inspection
- natural health product industries
- pharmaceuticals
- research and development
You will gain knowledge of the regulatory system, legislation, procedures and practices related to the development, manufacture, quality assurance and marketing of health-related products. Expert instruction and real-world experience gained through a work placement will give you the skills and knowledge you need to enter this highly competitive field.
Following two academic course-based semesters, students complete a three-month (450 hours) internship work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Internship placements 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 Semesters 3, students complete their learning on placement sites, and assessments are carried out by assigned supervisors at the site of placement. Humber assists students in finding their placements by working with our industry partners to identify openings. Students are responsible for finding their own work placement that is aligned with learning outcomes of our program.
Courses
Semester 1 |
Winter 2021 Delivery | Proposed Summer 2021 Delivery | Note |
|---|---|---|---|
| REGA 5020: Health Care Legislation, Regulation and Guidelines | Not Running | Not Running | |
| REGA 5021: Product Development-Premarket | Not Running | Not Running | |
| REGA 5022: Product Development-CMC | Not Running | Not Running | |
| REGA 5023: Medical Products Safety | Not Running | Not Running | |
| REGA 5024: Communication | Not Running | Not Running | |
| REGA 5025: Pathophysiology and Pharmacology | Not Running | Not Running |
Semester 2 |
Winter 2021 Delivery | Proposed Summer 2021 Delivery | Note |
|---|---|---|---|
| REGA 5030: Management of Regulatory Submissions | Online | Not Running | |
| REGA 5031: Management of Global Regulatory Submission | Online | Not Running | |
| REGA 5033: Regulation of Food Products and Agrichemicals | Online | Not Running | |
| REGA 5034: Medical Devices | Online | Not Running | |
| REGA 5035: Provincial Formularies and Reimbursement Policy | Online | Not Running | |
| REGA 5036: Emerging Biotechnology | Online | Not Running |
Semester 3 |
Winter 2021 Delivery | Proposed Summer 2021 Delivery | Note |
|---|---|---|---|
| REGA 5040: Internship | Online/In-Person |
Internship (Field Work)-Can be carried out online or in-person depending on the industry offering and positions obtained-Students need to be available for either format as required by the industry |
|
| REGA 5041: Integrative Seminar | Online |
Current students, please make sure to review your MyHumber Academic Progress report to confirm which courses you should register into for your Winter semester. Courses with in-person requirements will likely also have online components. Humber may need to change plans for in-person learning, subject to government and public health directives and/or additional health and safety considerations.
Admission Requirements
Applicants must meet all the requirements below in order to meet minimum program eligibility. Meeting minimum eligibility requirements does not guarantee an offer of admission. Admission decisions will be available via MyHumber, or by email and mail. Admission decisions will not be released by phone.
Admission selection is based on the following 5 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 program eligibility.
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 WES or ICAS evaluation.
- .
Resume
Applicants must submit a detailed resume including education, work, and/or volunteer experience. Excellent resumes contain experiences that are relevant to the subject of interest. The resume itself should be well organized and easy to follow. Standard Canadian spelling and grammar should be used.
- .
Video Introduction
Applicants must submit a 3-5 minute video introduction outlining their interest in this field of study. The video should express why the applicant has an interest in Regulatory Affairs specifically in Humber College’s Regulatory Affairs graduate certificate program.
Expectations for Video Introduction
The video should include the use of clear and concise language that uses appropriate pace, tone, and projection of voice. Hand gestures should be kept to a minimum and when they are used, should add to the presentation style rather than distract.The video must be within the time allowed.
The video should contain a clear and compelling rationale for the applicant’s interest in the subject. A specific rationale for wanting to study at Humber College should be included and will demonstrate an understanding of the demands of the graduate certificate.
Submission Instructions
https://humber.ca/admissions/office-of-the-registrar/registration/submission-instructions.html
How to Apply
Applications are made through ontariocolleges.ca. See program page for details.
International Academic Equivalency
Admission equivalencies for Humber depend on your country of study. Please see admission requirements on the program page to enter your location.
Fees
The 2020-2021 fee for three semesters is:
- domestic: $7,141.11
- international: $25,330.50
Fees are subject to change.
Domestic Fees by Semester
| Semester 1 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $1,859.15 | $1,859.15 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $2,378.06 | $2,238.70 |
| Semester 2 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $1,859.15 | $1,859.15 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $2,378.06 | $2,238.70 |
| Semester 3 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $1,859.15 | $1,859.15 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $2,378.06 | $2,238.70 |
International Fees by Semester
| Semester 1 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $7,784.59 | $7,784.59 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $8,303.50 | $8,164.14 |
| Semester 2 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $7,784.59 | $7,784.59 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $8,303.50 | $8,164.14 |
| Semester 3 | Original 2020-2021 Fees | Updated Fall 2020 Fees |
| Tuition | $7,784.59 | $7,784.59 |
| Compulsory Ancillary Fee | $434.91 | $319.30 |
| Compulsory Student Union Fee | $64.00 | $60.25 |
| Optional Student Union Fee | $20.00 | $0.00 |
| Program Ancillary Fee | $0.00 | $0.00 |
| Co-op/Placement | $0.00 | $0.00 |
| Total | $8,303.50 | $8,164.14 |
*Plus Mandatory Health Insurance fee once per academic year: Fall start - $420 Winter start - $280 Summer start - $140
Equipment & Device Requirements
Semester 1
| Details and Specifications | Minimum Specifications | Recommended Specifications |
| Processor | Intel i5-8300H | Intel i5-8300H |
| OS | Windows 10 | Windows 10 |
| 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 |
Pathways
Humber offers a number of transfer options and pathway opportunities. Visit humber.ca/transferoptions or refer to the program page.
Contact Information
Program Specific Questions
Michael Lavallee, program co-ordinator
Faculty of Health Sciences & Wellness
416.675.6622 ext. 5301
michael.lavallee@humber.ca
healthsciences.humber.ca
Admissions Questions
Domestic Students
416-675-5000
enquiry@humber.ca
International Students
Contact the International Centre
international.humber.ca/contact
1-416-675-5067
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.
On October 21, 2019, the Provincial Government of Ontario announced the renaming of the Ministry of Training, Colleges and Universities (MTCU) to the Ministry of Colleges and Universities (MCU). Both names may appear on this website.
Select information only is included in this printable PDF. For complete program details, refer to humber.ca/programs.
Print/Download Date: April 11, 2021