Masters in regulatory affairs in canada

Last Updated on August 24, 2022 by

Are you a graduate interested in earning your Masters in Regulatory Affairs in Canada? If you are, then you have probably been asking yourself this question: “What is the best course to take?” This can make your decision even tougher to make. After all, there are more than twenty accredited schools that provide programs related to regulatory affairs. However, there are several other factors you will want to consider so that you can make an informed choice and avoid any future regrets.

Collegelearners affords a plethora of information on regulatory affairs courses in canada for international students, ms in regulatory affairs in usa, is a masters in regulatory affairs worth it and so much more. Ensure you peruse through our catalogue for relevant information on similar topics.

Masters in regulatory affairs in canada

OVERVIEW

The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring highly regulated products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs. This unique graduate degree is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.

Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a highly regulated product to market, both in the U.S. and around the globe.

Northeastern’s MS in Regulatory Affairs offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:

  • Biopharmaceutical Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • Medical Device Regulatory Affairs 
  • Nonclinical Biomedical Product Regulation
  • Quality Assurance and Compliance 


The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring highly regulated products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs. This unique graduate degree is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.

Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a highly regulated product to market, both in the U.S. and around the globe.

Northeastern’s MS in Regulatory Affairs offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:

  • Biopharmaceutical Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • Medical Device Regulatory Affairs 
  • Nonclinical Biomedical Product Regulation
  • Quality Assurance and Compliance 

More Details

Unique Features

  • Students will have the opportunity to study biomedical product regulations directly applicable to commercialization of these products in Canada.
  • Students can focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
  • Students will participate in integrative experiential learning and/or the cooperative education program as part of their course of study.
  • Students will have the opportunity to forge connections with our global network of alumni from some of the world’s most renowned companies, including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestle, Pepsico, and Coca-Cola.
  • As a Northeastern University student and alumnus, you’ll have access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.

Program Objectives

Successful completion of the MS-RA Program will enable students to:

  • Gain the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment.
  • Acquire the professional foundations necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, clinical research, and food safety.
  • Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
  • Refine your understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of drugs, biologics, medical devices, and food safety.
  • Analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations.

Concentrations

  • Biopharmaceutical Regulatory Affairs—Learn how to apply statuses to the submission of marketing approval applications for both pharmaceutical and biological products to global regulatory agencies.
  • Clinical Research Regulatory Affairs—Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support biomedical product development.
  • Medical Device Regulatory Affairs—Learn how to apply statutes of the submission of marketing approval applications for medical device products to global regulatory agencies.
  • Nonclinical Biomedical Product Regulation—Study the regulations applicable to biomedical product commercialization from pre-clinical development, quality, and manufacturing perspectives.
  • Quality Assurance and Compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products.

Program Approval and Accreditation

This institution has been granted consent by the Minister of Colleges and Universities to offer this degree program for a five-year term starting June 25, 2021. Prospective students are responsible for satisfying themselves that the program and the degree will be appropriate to their needs (e.g., acceptable to potential employers, professional licensing bodies or other educational institutions).

For International Students

This program is eligible for a Canadian Study Permit and Post Grad Work Permit (PGWP). For more information on studying in Canada—including how to apply for a Study Permit—please visit our Office of Global Services’ Canadian Campuses page.

ADMISSIONS

A graduate degree or certificate from Northeastern—a top-50 university—can accelerate your career through rigorous academic coursework and hands-on professional experience in the area of your interest. Apply now—and take your career to the next level.

Program Cost

$36.4K *

PROGRAM COST (CAD)

$2.2K

AVG INSTITUTIONAL AID

International Students Tuition rate for International (Non-Canadian Resident): $40,185 CAD

Requirements

  • Online application
  • Unofficial undergraduate/graduate transcripts (you can submit official transcripts from all colleges/universities attended at the time of admission)
  • Statement of purpose that should include career goals and expected outcomes and benefits from the program
  • Recent professional resumé listing detailed position responsibilities
  • Two confidential letters of recommendation 

As an international student, there are a number of documents you need to study in Canada.

  • Valid passport: applications can take up to three months (or longer), so apply as soon as possible
  • Study permit: all international students in programs longer than six months need a valid study permit
  • Temporary Resident Visa (TRV) & Electronic Travel Authorization (eTA)­
    • Only citizens of certain countries require a TRV
    • If you are from a TRV-exempt country, you may need to apply for an eTA before you can travel to Canada

You are responsible for maintaining your immigration status and complying with immigration regulations while you are in Canada.

is a masters in regulatory affairs worth it

Whether you realize it or not, you cross paths with the regulatory affairs industry on a daily basis. In fact, 25 cents of every dollar spent by American consumers go toward a product or service regulated by the Food and Drug Administration (FDA). Each food, beverage, cosmetic, prescription medication, or vitamin you purchase has undergone rigorous regulatory checks for safety and efficacy on its path to supermarket shelves.

But it’s not just food and prescription drugs that need to be approved for human consumption. All medical technologies, including medical equipment, implanted devices, and biotechnological advancements, are also subject to federal and international regulation to ensure their safety, efficacy, and performance.

Despite these stringent regulations, the rapid development of new medical technology and the increasing accessibility of food from around the globe introduce new risks to the market daily. Thus, it is now a global imperative to develop and improve state, federal, and international regulations to maintain the innovation and release of food and biomedical products to global markets. To do this, we rely on the expertise of regulatory professionals.

Are you interested in gaining this expertise and breaking into a growing industry? Here’s an overview of the regulatory affairs industry, including careers and trends, to help you navigate the field.

Download Our Free Guide to Advancing Your Regulatory Affairs Career
Learn how to navigate the discipline and accelerate your regulatory career.

What is regulatory affairs?
Regulatory affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.

Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.

Careers in Regulatory Affairs
There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:

Regulatory affairs specialist
Regulatory affairs manager
Regulatory affairs director
Compliance specialist
Food safety inspector
Clinical research associate
Director of quality assurance
These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world. But what do these professionals actually do on a daily basis?

What do regulatory affairs professionals do?
According to Stephen Amato, PhD, associate teaching professor, and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs program, the answer is, “It depends.”

Because the field of global regulatory affairs spans a diverse set of disciplines, including law, economics, public policy, health, and science, the scope of a regulatory professional’s work varies. Career paths and daily responsibilities may differ based on areas of expertise, but all regulatory professionals have one goal in common: to facilitate the commercialization of safe and effective products and services. Some regulatory affairs professionals manage clinical studies or develop marketing approval policies, while others design labels for food- and drug-related products.

One of the most common titles in the industry is regulatory affairs specialist. These specialists analyze new and existing regulations in relation to an organization’s products or processes. They also review marketing, legal, and technical documentation, including case files and clinical research reports, to assess compliance with global regulatory agency policies, regulations, and standards. Regulatory affairs specialists may also recommend courses of remediation to help companies achieve the necessary levels of compliance. Acting as a liaison between manufacturing organizations and federal agencies, they may be responsible for submitting critical regulatory documents, with the goal of approval for sale and distribution.

Senior-level regulatory professionals often make strategic business decisions that have significant legal and financial repercussions. A large part of a regulatory affairs role, at all levels, is to interpret and communicate these implications to a diverse set of internal and external stakeholders.

Regulatory professionals are also often a voice in conversations at the cutting edge of health and public policy. Darin Detwiler, PhD, assistant dean, and director of Northeastern’s Master of Science in the Regulatory Affairs of Food and Food Industries program, says that regulatory work is more than a job; it’s a mission.

He says his goal as a regulatory leader and educator, “is not just to send students forth with degrees, but to build effective leaders and change agents in the health and food industries. [Regulatory work] is a big part of the solution to major public health and food safety challenges.”

What’s the job outlook and market demand?
As the regulatory affairs discipline plays an integral role in global health, food safety, and medical innovation, it’s no surprise that the job market is growing. In 2016, the U.S. regulatory market experienced a 42 percent increase in job listings, and the U.S. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until 2026. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase.

Where do regulatory affairs professionals work?
Along with the promise of job security, pursuing a career in regulatory affairs affords you a great deal of flexibility in where you choose to work.

As of 2018, 73 percent of regulatory professionals work directly in a regulated industry, such as pharmaceuticals, medical devices, biotechnology, or food science. Just under eight percent choose a consultative path, gaining employment at legal, research, or marketing firms. The remainder are employed by a mix of academic institutions, clinical research organizations, government agencies, hospitals, and healthcare organizations. With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees.

What do regulatory affairs professionals earn?
Much like the setting and scope of a regulatory job, regulatory salaries vary, depending on job function, previous regulatory experience, seniority, geographic market, and highest earned degree.

And as market demand has increased, employers are willing to pay more for the right level of skill. Since 1995, salaries across all regulatory professions have maintained a general upward trend, increasing by an average of 3.3 percent per year. As of 2016, the average yearly salary for regulatory professionals at all levels was $150,422.

According to the Regulatory Affairs Professional Society’s (RAPS) 2018 report, the national average total compensation for U.S.-based regulatory professionals by job level is:

Vice President: $256,500
Director: $189,000
Manager: $139,000
Project Manager: $128,000
Specialist: $123,000
Associate: $93,000
What education and training are required for a career in regulatory affairs?
“Breaking into the global regulatory affairs industry is in many ways unlike pursuing medicine or law, where the path to a successful career may be more established or clear-cut,” Amato says.

Unlike these areas, effective regulatory professionals come from a variety of backgrounds; there is no one degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business.

What’s encouraging to aspiring industry workers is a large percentage of current regulatory professionals began working in a different industry before transitioning into regulatory affairs, according to the 2018 RAPS report. Most of these individuals worked first in related industries, such as quality assurance and quality control, research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering.

A majority of regulatory workers earn undergraduate degrees in the disciplines of life science, clinical science, public health, or engineering, but others begin in unrelated areas, such as business, economics, or liberal arts. Regardless of your undergraduate focus, most prospective employers are more concerned with finding someone who possesses advanced regulatory knowledge and hands-on experience—two qualifications you can gain in a graduate program.

Earning an advanced degree in regulatory affairs will not only make you more marketable to employers, but it will also yield career opportunities that might have otherwise been inaccessible. According to the 2018 RAPS report, more than 99 percent of regulatory professionals hold a university-level degree, and 44 percent of regulatory professionals hold a master’s degree.

Current Trends in Regulatory Affairs
According to Amato and Detwiler, there are several emerging trends influencing hiring patterns in the industry. These advances will likely expand the scope of work for regulatory professionals and shift employer demand toward new skills. Some of these trends include:

Electronic Common Technical Document (eCTD)
The FDA recently passed legislation requiring a new electronic format for regulatory submissions, spurring development of new software platforms and accompanying protocols. Individuals who acquire this eCTD competency will be in high demand.

Blockchain
Food industry stakeholders around the globe are uncovering ways to use blockchain technology to improve the transparency, efficiency, safety, and authenticity of food supply chains. With a number of new organizations entering the blockchain supply chain arena, there will be an increase in hiring regulatory leaders to support their strategic vision.

Social Media
Companies in regulated industries are beginning to focus on the use of social media to market products. As social platforms evolve, organizations seek to develop guidelines to regulate social communication and language to ensure consistency with product and labeling information. Individuals who stay abreast of these industry changes and keep their skill sets current will be well-positioned for future jobs.

How to Start Your Career in Regulatory Affairs
Amato says while regulatory job openings are abundant, companies are struggling to find the right level and combination of skills to fulfill their needs. Here are some suggestions for developing a competitive advantage to land the job:

  1. Stay current.
    The work of regulatory professionals is continuously shifting and expanding due to evolution in law, regulatory environments, technology, and global economics. Keep your regulatory knowledge base current by scanning multiple sources of regulatory affairs material daily to stay up-to-date on global changes in food and drug regulation.

Amato’s favorite sources include the U.S. Food and Drug Administration, Federal Register, and Drug Information Association. Subscribing to updates from publications such as Food Safety Magazine or Medical Device Manufacturers Association can also provide you with industry-specific updates to help you stay relevant.

  1. Sharpen your skills.
    Regulatory projects are usually complex, time-constrained, cross-functional, and resource-intensive. Be proactive and focus on refining skills that complement this type of work, such as strong communication, critical and analytical thinking, negotiation techniques, project management methods, and a collaborative mindset.
  2. Develop a global perspective.
    According to the 2018 report, 51.5 percent of regulatory professionals have worldwide responsibilities, and the number is likely to keep growing due to an increasing number of interconnected global regulations. Despite recent efforts to harmonize global regulations, many policies still diverge significantly. Regulatory professionals who can synthesize this information on a global scale to produce efficient, culturally agile programs will be highly valued.
  3. Get hands-on experience.
    Detwiler says the real work of a regulatory specialist is not performed at a desk, but rather “in the manufacturing plant, the lab, the boardroom, or on the Senate floor.” In order to move beyond theory and into practice, you need to have real-world experience.

Gaining an advanced degree in regulatory affairs is one way to gain this experience and help you translate knowledge into action. At Northeastern, students in the regulatory affairs program have the opportunity to work alongside faculty on short-term, real-world projects at leading organizations. If you’re not ready to commit to graduate studies, seek out and take advantage of other experiential learning opportunities, such as internships or hands-on research.

  1. Find your network.
    Locate mentors embedded in the industry to help advance your career. At Northeastern, graduate students have access to a global network of more than 3,000 employer partners and 230,000 active alumni, who work at leading biotech companies and global brands such as Pfizer, Biogen, Sanofi Genzyme, Boston Scientific, Merck, Kellogg’s, United Airlines, and Coca-Cola.

Organizations such as the Regulatory Affairs Professional Society and The Organization for Professionals in Regulatory Affairs offer global education, training, networking, research support, and other valuable career development resources. Get involved with these groups to strengthen your network and get ahead.

The world of regulatory affairs is far-reaching and constantly evolving, making it a dynamic choice for a career. As market demand continues to grow, it’s an opportune time for professionals of all levels to enter the field.

Getting Started in Regulatory Affairs
As always, there are several key considerations you should explore in order to determine if a career in regulatory affairs is right for you. Most importantly, you should evaluate both your personal and professional goals to better understand how a career in regulatory affairs can help you meet your goals.

Earning an advanced degree in a related field of study can prepare you for this competitive and in-demand career. Northeastern’s Master of Science in Regulatory Affairs program equips students with the knowledge and skills needed to succeed in the various careers within the regulatory industry.

ms in regulatory affairs in usa

Universities for MS in Regulatory affairs in USA

1 Northeastern University
2 St. Cloud State University
3 University of Florida (UFL)
4 Johns Hopkins University (MS in Bioscience Regulatory Affairs)
5 National University (MS in Clinical Regulatory Affairs)
6 USC – Masters in Regulatory Affairs
7 LIU – Drug Regulatory Affairs
8 University of Georgia

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