Regulatory Affairs and Quality Operations (Co-op)
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Program Overview
Companies that intend to develop and commercially distribute regulated pharmaceuticals and life-science products are required to have knowledge of 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.
Program Details
Program Code
RAQ2
Credential:
Ontario College Graduate Certificate
Duration
30 Weeks
Start Dates
Locations
Availability
Full Time Offerings
2025 September
London
Open
2024 September
London
Closed
Start Dates
Locations
Availability
Full Time Offerings
2025 September
London
Open
2024 September
London
Closed
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.
Career Information
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
Learning Outcomes
- 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 to 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 in accordance with 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
Admission Requirements
One of:
Ontario College Diploma, Ontario College Advanced Diploma,
Degree in a health or science related field.
OR
equivalent qualification from another institution as judged by
the College
OR
equivalent professional background and experience as judged by
the College
International Admission Equivalencies
Admission equivalencies for Fanshawe depends on your country of study. Please enter your location to see the requirements for your country below.
English Language Requirements
English Language Requirements
| Test | Score |
|---|---|
| TOEFL iBT | 88 |
| IELTS Academic | Overall score of 6.5 with no score less than 6.0 in any of the four bands |
| CAEL | Overall score of 70 with no score less than 60 in any of the four bands |
| PTE Academic | 59 |
| Cambridge English | Overall score of 176 with no language skill less than 169 |
| ESL4/GAP5 | Minimum grade of 80% in Level 9, 75% in Level 10 |
| Duolingo | Overall score of 120, with no score lower than 105 |
Recommended Academic Preparation
Recommended Academic Preparation
- Previous business or IT post-secondary education and/or training and/or work experienceApplicant Selection Criteria
Applicant Selection Criteria
Where the number of program eligible applicants exceeds
available spaces, the Applicant Selection Criteria for this program
will be:
1. Preference for Permanent Residents of Ontario
2. Receipt of Application by February 1st (After this date,
Fanshawe College will consider applicants on a first-come,
first-served basis until the program is full)
3. Achievement in the Admission Requirements
Courses
| Level 1 | ||||
| Take all of the following Mandatory Courses: | ||||
| HLTH-1301 | Comm & Documentation in Reg Affairs 1 | 4 | ||
| This course will introduce students to topics in regulatory document preparation such as standard operating procedures (SOP), records of training, batch documents, change control, stability documents, deviation, and investigation reports. Students will practice focused writing techniques appropriate to regulatory affairs. | ||||
| HLTH-1302 | Introduction to Regulatory Affairs | 4 | ||
| This course introduces healthcare product regulation Canada as positioned in a global market. It provides an overview of the lifecycles and regulatory processes of pharmaceuticals, medical devices, and natural health products, highlighting the principles and applicable legislation, regulations and guidelines that drive these processes. | ||||
| LAWS-6043 | Principles of Cannabis Regulations | 3 | ||
| Regulations surrounding cannabis production and processing will be explored. Fundamental aspects of internal and external laboratory auditing will be taught. Students will prepare an audit plan for meeting laboratory accreditation requirements. Bioethics will be introduced relative to the moral issues of cannabis regulatory compliance. Specifics of Cannabis testing requirements while following the Cannabis regulations are taught. Safe Foods for Canadians Regulations as it pertains to edible cannabis products are examined. | ||||
| PHRM-1071 | Regulatory Affairs in Pharmaceuticals | 4 | ||
| Course topics will include application and documentation processes involved in drug manufacturing, preparation and release of products by international standard requirement(ISO), specialized documentation for marketing of pharmaceuticals and biologics, and the socio-economic impact of introducing a new drug or biological therapeutic products (i.e. vaccines). | ||||
| PHRM-1073 | Regulated Chemicals & Biologics | 2 | ||
| This course provides an overview of different chemicals and biological materials used in pharmaceutical and biotechnology industries. Students will also learn about safety precautions and regulatory documentations of these materials, as well as Canadian regulatory processes about hazardous chemicals. | ||||
| MGMT-6084 | Project Management | 4 | ||
| This course introduces the essentials of the project management discipline, and prepares students to manage project teams, project schedules, budgets and quality requirements. Students learn the process of analyzing, creating and managing a functional project plan and the various project management processes for managing and controlling a project through to fruition. This course brings all of the Project Management Institute (PMI) knowledge areas of project management together into a consolidated whole, and gives the student an understanding of project management methodologies as well as the tools and techniques used to plan, execute and control various types of projects. | ||||
| PHRM-1069 | Introduction to Capstone Project | 1 | ||
| The purpose of a capstone project is to provide students with the opportunity to apply the knowledge and skills learned across all courses in the program to a large-scale project that's reflective of a real-life work situation. This course is the first phase of the capstone project, where students will receive an overview of the project parameters and begin planning for both their individual and group contributions. | ||||
| COOP-1020 | Co-operative Education Employment Prep | 1 | ||
| This workshop will provide an overview of the Co-operative Education consultants and students' roles and responsibilities as well as the Co-operative Education Policy. It will provide students with employment preparatory skills specifically related to co-operative education work assignments and will prepare students for their work term. | ||||
Tuition Summary
London
*Total program costs are approximate, subject to change and do not include the health and dental plan fee, bus pass fee or program general expenses.