Regulatory Affairs

Program Code:  07721
Credential:  Ontario Graduate Certificate
Start Dates:  September
Program Length:  3 semesters

 

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 which 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.

 

 

 

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 five requirements:

1. Academic
 

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

2. 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.

 

Applicants must submit a 2-3 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.

 

 

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.

4. English Language Proficiency
 

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

 

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.

 

 

 

The medical, pharmaceutical, food, and natural products industry is facing constant development. As a society focused on health and wellness as well as safety and efficacy much attention is being given to the safe development of new interventions, supplements, and drugs as well as the improvement of society’s overall health and wellbeing. Comprehensive training combined with work experience and previous degrees makes Humber students highly marketable.

 

In the Industry
Regulatory Affairs Specialists help the government and businesses to ensure that product development, manufacturing, and marketing practices meet government standards and ensure products are safe for public use. Regulatory affairs is a mandatory and necessary undertaking (ethically and regulatorily) in development, inspection, quality assurance, and safety assessment of new and existing consumable, therapeutic, and diagnostic products.

Compliance Rules Law Regulation Policy Business Technology concept.

 

The Humber Advantage 
 

Industry Recognition
Every year our program receives excellent feedback from the industry regarding the professional preparation of the graduates and the content of the program; our graduates are an important resource for the industry. This is an outcome of our ongoing efforts to ensure that students have a solid understanding of regulatory affairs and field-specific knowledge.

The Regulatory Affairs Graduate Certificate program at Humber is strategically designed, developed, and delivered with high efficiency, during the first two semesters of the program. Subsequently, theoretical learning is extensively applied through hands-on experiences during the 3rd semester, including a 450-hour internship placement.

 

The fundamental skills are taught, developed, and reinforced throughout the one-year comprehensive program. Work-ready graduates are developed in this program to confidently transition into the workforce.

 

The Right Fit
 

If you are policy and guidelines-oriented, self-regulated, have collaborative interpersonal skills and enjoy critical thinking, the Regulatory Affairs program and a career in this field may be for you.

 

Note: Check with the institution regarding start/end dates, prices, and delivery method. These may vary according to program, section, and/or semester.