Graduate Certificate in Regulatory Affairs & Quality Operations
London, Canada
DURATION
30 Weeks
LANGUAGES
English
PACE
Full time
APPLICATION DEADLINE
Request application deadline
EARLIEST START DATE
Sep 2025
TUITION FEES
CAD 25,752 *
STUDY FORMAT
On-Campus
* for international costs | Canadian costs: CAD 5,403.88
Introduction
Companies that intend to develop and commercially distribute regulated pharmaceuticals and life-science products are required to know the full spectrum of regulatory requirements in those industries. This program will provide students with the in-depth knowledge and hands-on training required to assist with navigating regulatory approval processes, primarily for pharmaceuticals, biotechnology, and medical devices with a secondary focus on food and herbal products. Students will specifically learn the process for developing successful regulatory applications that allow companies to proceed with the development and launch of new products.
Your Learning Experience
RAQ1 is the 2-year version of this program available to international students only. RAQ2 is the 1-year version of the program available to International and Canadian students.
Students will develop the strong communication, negotiation, and project management skills necessary for the preparation of successful regulatory affairs applications and documentation. They will also practice their attention to detail and strategic thinking skills, all of which are critical for career progression within the highly competitive pharmaceutical and biotechnology industries. Students’ real-world experience is enhanced through a co-op work experience that is included in the program.
CIP Code: 51.0000
Admissions
Curriculum
Level 1
Take all of the following Mandatory Courses:
- Comm & Documentation in Reg Affairs 1
- Introduction to Regulatory Affairs
- Principles of Cannabis Regulations
- Regulatory Affairs in Pharmaceuticals
- Regulated Chemicals & Biologics
- Project Management
- Introduction to Capstone Project
- Co-operative Education Employment Prep
Level 2
Take all of the following Mandatory Courses:
- Health & Biosafety Regulations
- Comm & Documentation in Reg Affairs 2
- Bioethics in Life Science
- Clinical Research Regulations
- QA in Pharmaceuticals & Life Science
- Food Safety, Traceability & QA
- Capstone Project
Program Outcome
- Analyze, synthesize and apply provincial, federal, and international regulatory processes as they relate to pharmaceutical, food, cannabis, biotechnology and medical device products.
- Execute quality assurance and quality control processes to ensure compliance with Canadian and global regulatory requirements.
- Employ appropriate use of IT software and systems to document, compile, manage and save content and data specific to regulatory affairs projects.
- Use a wide range of data analysis methods to support decision-making processes.
- Apply project management and risk management principles to the successful completion of regulatory submissions.
- Conduct an industry and socio-economic impact analysis regarding the introduction of a new product and/or policy.
- Work collaboratively with product development teams, applying leadership techniques to complete projects by project timelines.
- Identify and apply regulatory strategies that contribute to and promote health equity in diverse communities.
- Examine the role of Canadian regulatory affairs professionals and participate in professional development activities to maintain currency in a changing regulatory affairs landscape.
- Adhere to the International Organization for Standardization (ISO), Therapeutic Products Program (TPP) and bioethical protocols and guidelines for drug, medical device, and biological product submissions.
- Adhere to regulations when conducting pre-clinical and clinical studies of biological products.
- Adhere to the use of appropriate communication conventions and tools when compiling and submitting regulatory affairs documents.
Program Tuition Fee
Career Opportunities
Graduates of this program will be prepared to secure positions with government departments and agencies, consulting establishments, universities, research institutes, hospitals, community agencies, educational institutions, professional associations, non-governmental and international organizations in a variety of roles such as:
- Regulatory Affairs Associate
- Regulatory Affairs Assistant
- Quality Assurance Associate
- Quality Assurance Investigator
- Documentation Administrator
- Medical Information Associate
- Health Policy Researcher
- Consultant
- Program Officer