MS in Regulatory Affairs in Canada

Last Updated on December 13, 2022 by

Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements. Key duties of the job include: studying scientific and legal documents. gathering, evaluating, organising, managing and collating information in a variety of formats.

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MS In Regulatory Affairs In Canada

Program Description

This is Canada’s only master’s degree in regulatory affairs, focused on the development and commercialization
of drugs, biologics, and medical device products.

Key differentiators of our program:

  • Six unique concentrations: Operational Regulatory Affairs, Strategic Regulatory Affairs, Clinical Research Regulatory Affairs, International Regulatory Affairs, Regulatory Compliance, or General Regulatory Affairs.
  • Choose the learning format that meets your needs (100% online or flexible hybrid format that combines online and in-class instruction).
  • Experiential learning: Acquire hands-on experience through in-the-field research, capstone projects, co-op opportunities, or an integrative learning experience at your current employer.

Admissions at the College of Professional Studies operates on a rolling basis, meaning that applications are reviewed as they are received, and there are multiple intakes over the course of the academic year. See below for upcoming academic terms along with the application deadline for each.

Admissions Requirements

  1. 1. Online application
    2. Statement of purpose (500-1000 words)
    3. Professional resumé
    4. Unofficial undergraduate transcripts
    5. Two letters of recommendation
    6. English Language Proficiency Proof: Students for whom English is not their primary language must submit one of the following:
    • Official bachelor’s degree transcript from an accredited college or university in the US, stating degree conferral and date
    • TOEFL, IELTS, Pearson (PTE), or NU Global Exam scores.
Pharmaceutical Regulatory Affairs & Quality Operations - Seneca, Toronto,  Canada

Program Objectives

  • Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment.
  • Acquire the foundation necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, and clinical investigations.
  • Examine every step of the drug development and regulation process.
  • Sharpen your understanding of the laws that govern the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices.
  • Analyze how emerging developments and trends are reshaping medical device regulations.

Find out more

Generally speaking, the pharmaceutical and medicine manufacturing industry is not highly sensitive to changes in economic conditions—consistently experiencing growth in both jobs and profits. Because they are relied upon to get new drugs and devices tested, approved, and put on the market, regulatory affairs specialists are continually in demand. While employment prospects are bright across the field, regulatory affairs professionals with the most education are likely to enjoy the most opportunities and highest pay.

Program Overview

Humber’s Regulatory Affairs graduate certificate program prepares graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This 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.

You will also benefit from:

  • Two academic semesters
  • A subsequent third semester internship placement carried out post academic semesters
  • Case studies and projects mimicking real work experiences
  • Integrative project work that links applied and academic fields
  • Acquiring a recognized skillset applicable to a wide variety of employment opportunities
  • Learning to adapt to the changing field and stay current

Work Placement

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.

Professional Regulatory Affairs | Pharmaceutical Diploma Program | AAPS

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.

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 regulatory) in development, inspection, quality assurance, and safety assessment of new and existing consumable, therapeutic, and diagnostic products.

An education in high demand

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 make Humber students highly marketable.

Regulatory Affairs Specialist |

The Humber Experience

Superior Program Design

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 hours 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.

Mission Statement

It is our vision and mission to offer our learners the means to excel in the field of Regulatory Affairs by providing industry relevant professional, technical, theoretical, and hands-on experience. We strive to develop work ready learners upon graduation through a collaborative partnership between students and the program. The internship component of this program, which follows two academic semesters, provides students a practical environment and offers ample opportunities to integrate theoretical learning into real industry hands-on experience. Additionally, the internship placement will provide students an opportunity to expand their professional network through interaction with peers, faculty and colleagues. It is our hope that upon graduation students will effectively and confidently transition to work force, related to their field of study.

Your Career

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

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best universities for ms in regulatory affairs in canada

A master’s in pharmacy can be obtained from some of the top-ranking Canadian universities. Apart from studying MS in pharmacy from Canada, international applicants can also opt for similar programs like masters in pharmacology and pharmaceutical sciences. Given below is a detail of the universities offering masters in pharmacy program:

Country RankingsWorld RankingsUniversityProgram Fee/Year (USD) (approx)Brochure
#1#25University of Toronto39,926Download Brochure
#5#119University of Alberta12,670Download Brochure
#7#166University of Waterloo11,300Download Brochure
#16#458University of Saskatchewan10,096Download Brochure
#20#601-650University of Manitoba19,648Download Brochure
#23#751-800Memorial University of Newfoundland (MUN)7,248Download Brochure

Top Masters in Pharmacy Courses in Canda

Here are some of the top master’s in pharmacy courses in Canada,

Name of UniversityCourse NameFees/Year (EUR)Duration of Course
University of ManitobaPharmacy80912 years
University of Toronto Pharmacology189532 years
University of British ColumbiaPharmacology61652 years
University of ManitobaPharmacology and Therapeutics80912 years
Western University CanadaPhysiology and Pharmacology87162 years
McGill UniversityPharmacology64252 years
University of TorontoPharmacy432982 years
Fanshawe CollegeCannabies Applid Science110011 year
Dalhousie University Pharmacology90062 years
University of SasketchwenPharmacy46352 years

northeastern university regulatory affairs requirements

Academic Eligibility:

  • Students must complete a 4 years bachelor’s degree from a recognized institution.

Indian Student Eligibility:

Indian students are eligible to apply if they meet one of the following eligibility criteria:

  • Completed a 4-year UG degree with first class in a relevant field from a recognized institution

Along with the minimum eligibility requirements, international students hailing from non-English speaking countries need to prove English proficiency through IELTS/TOEFL/any equivalent test to get admission to this program.

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