Regulatory Affairs - Sciences
Pursue a career in protecting the safety of people and the environment.
- Focuses on industrial, food, and health sciences, a great blend for those interested in, or with a background in, the sciences (biology, and environmental science), and policy
- Graduates are well positioned for a variety of entry-level employment opportunities in the regulatory affairs sector
- The regulation of products across industries is of growing international concern, driving the demand for qualified graduates
Program Availability and Schedule
Availability
Availability varies by course. Click here to view availability for courses in this program.
Schedule
Given the part-time delivery of this program, there is not a standard schedule for all learners.
Program Summary
Credential
Program Code
Area of Interest
Other Delivery Options
Eligible for Post-Graduation
Work Permit?
In this Regulatory Affairs - Sciences Ontario College Graduate Certificate program, you build on your existing science, engineering, or technology education to learn how pharmaceuticals, medical devices, agrochemicals, and industrial chemicals are regulated for public health and environmental protection. You also have an opportunity to choose specific areas of focus though project topic selection. The program prepares well-rounded regulation professionals who are knowledgeable about the regulatory life-cycle management of science-based products.
As a regulatory affairs professional, you develop the skills and knowledge necessary to work in the field through practical, hands-on applications. You research and analyze the requirements of applicable regulations, prepare regulatory submissions, identify strategies to support pre-market product approval, identify and apply best practices for regulatory compliance and post-market surveillance, and provide stakeholders with clear and concise guidance and communications....(read more)
Overview
Pursue a career in protecting the safety of people and the environment.
In this Regulatory Affairs - Sciences Ontario College Graduate Certificate program, you build on your existing science, engineering, or technology education to learn how pharmaceuticals, medical devices, agrochemicals, and industrial chemicals are regulated for public health and environmental protection. You also have an opportunity to choose specific areas of focus though project topic selection. The program prepares well-rounded regulation professionals who are knowledgeable about the regulatory life-cycle management of science-based products.
As a regulatory affairs professional, you develop the skills and knowledge necessary to work in the field through practical, hands-on applications. You research and analyze the requirements of applicable regulations, prepare regulatory submissions, identify strategies to support pre-market product approval, identify and apply best practices for regulatory compliance and post-market surveillance, and provide stakeholders with clear and concise guidance and communications.
The breadth of the program means that your knowledge and skills are applicable in large industrial sectors involving pharmaceuticals, medical devices, agrochemicals, and industrial chemicals. Governments and industries require your expertise to capture the benefits of these products for the economy and society while ensuring their safety and efficacy for public health and the environment.
You have the option to gain real-world experience through a paid co-operative education (co-op) work term (see Additional Information for more details). Please note that places in the co-op work term are subject to availability and academic eligibility. Admission to the co-op program does not guarantee a co-op placement.
After graduating from this program, you are prepared to respond to employer needs at various product life cycle stages, such as:
- pre-market risk assessment processes
- management of post-market regulatory compliance systems
- surveillance and monitoring of products on the market
- public risk communications and consultations
- industry regulation strategies for product development
- regulation design
- regulation policy analysis
To qualify for this graduate certificate, you must complete the program within four years.
Courses
Read this before applying:
Part-time graduate certificate programs require you to complete an application and be accepted into the program prior to course registration. Please complete the application form before registering. Accepted students may register for up to three courses per term.
NOTE: This program has undergone significant curriculum changes as of the Fall 2025 semester. For students who are looking to complete the 2024-2025 program version and who may have concerns with progression, if you require assistance you can contact your Program Support Officer (if you are a part-time student) or your Student Advisor (if you are a full-time student) at https://www.algonquincollege.com/academic-success/ac-online/.
Online  |
| Course Number |
Hours | Course Name | Fall |
|---|---|---|---|
| Series: 01 | |||
| ENL2300 | 56.0 | Communication for Regulation Professionals | |
| RGL2300 | 42.0 | Law and Policy Governing Chemicals and Medical Devices | |
| RGL2400 | 42.0 | Science and Risk Assessment in Regulation | |
| RGL2500 | 42.0 | Theories, Concepts and Definitions in Regulation | |
| RGL2600 | 56.0 | Regulation Design and Approval Processes in Government | |
| RGL2800 | 56.0 | Pre-Market Regulatory Processes | |
| Series: 02 | |||
| RGL3400 | 42.0 | Post-Market Surveillance, Analytics and MonitoringPost-Market Surveillance, Analytics and Monitoring Post-market surveillance is a vital component of regulatory life-cycle management to protect public health and the environment. Students explore the risk monitoring objectives, technologies, and techniques of post-market surveillance, including reporting systems such as pharmacovigilance, and data gathering methods such as biomonitoring and ecosystem monitoring. Through case studies and comparative research, students assess how post-market surveillance relates to compliance promotion and enforcement of regulations, product advisories and recalls, and reversals or amendments to regulatory decisions. Pre-requisites: RGL2400 and RGL2500 There are no classes currently scheduled for this course. | |
| RGL3500 | 56.0 | Managing Life-Cycle Reg.Compliance Submissions for Pharma and Medical DevicManaging Life-Cycle Reg.Compliance Submissions for Pharma and Medical Devic Regulation professionals working in the pharmaceutical and medical device sectors, whether in government regulatory departments or private sector companies, must be aware of required regulatory compliance submissions throughout the product life cycle. Students explore guidance documents for the diverse types of pharmaceutical pre-market submissions, post-market pharmacovigilance reporting, and establishment licensing for Good Manufacturing Practices. Students also assess guidance for pre- and post-market submissions for Class II, III and IV medical devices. Finally, students explore the Electronic Common Technical Document (eCTD) submission standard adopted in Canada and other trading partners. There are no classes currently scheduled for this course. | |
| RGL3600 | 56.0 | Managing Life-Cycle Reg.Compliance for Agrochemicals and Industrial ChemicalsManaging Life-Cycle Reg.Compliance for Agrochemicals and Industrial Chemicals Regulation professionals responsible for the regulatory management of agrochemicals and industrial chemicals, whether in government regulatory departments or private sector companies, must be aware of required regulatory compliance submissions throughout the life cycle of these products. To inform risk assessment and risk management priorities, students explore guidance documents for pesticides, industrial chemicals, and polymers, such as requirements for pre-market submissions; pesticide incidence reporting; reevaluation of pesticides; new substances notifications; new activity notifications; and post-market reporting. There are no classes currently scheduled for this course. | |
| RGL3700 | 42.0 | Regulation and Industry Product Development ProcessesRegulation and Industry Product Development Processes Companies that undertake new product development increase likelihood of success by anticipating the effects of regulatory requirements on a product's functionalities and design characteristics. Students assess the impacts of regulations on industry product development decision-making. They explore the components of company regulatory strategies, including when and how regulation professionals must work with science and legal perspectives to protect the company's interests. Case studies addressing pharmaceuticals, agrochemicals, industrial chemicals, and medical devices illustrate the similarities and differences in regulatory impacts on product development. There are no classes currently scheduled for this course. | |
| RGL3800 | 42.0 | Public Risk Communications and ConsultationsPublic Risk Communications and Consultations Regulation is an information, communication, and consultation intensive profession. Students assess the dangers of information failures in the context of the public's involvement in the management of public health and environmental risk. Students also explore techniques for improving public consultations and risk communications to increase trust in organizations, reduce public uncertainty and anxiety, and mobilize communities to constructive risk avoidance action. Case studies on public risk consultations and communications are used to identify relevant techniques. Pre-requisites: RGL2400 and RGL2500 There are no classes currently scheduled for this course. | |
| RGL3900 | 56.0 | Regulatory Affairs Applied ProjectRegulatory Affairs Applied Project Designing and completing projects is a common task for regulation professionals. Students synthesize, integrate, and apply their knowledge to complete a self-driven project in a chosen specialization area consistent with the scope of the regulatory affairs program. Students identify a project, defend its relevancy, prepare a project workplan, and complete it through stages appropriate to the subject matter's demands. Students deliver documentation and presentations for guidance and approval at each project stage simulating a workplace scenario. Pre-requisites: RGL2400 and RGL2500 and RGL2800 There are no classes currently scheduled for this course. | |
Careers & Pathways
Careers
Graduates may find employment in government, industry, and consulting under a wide range of job titles, such as Regulatory Affairs Officer, Regulatory Compliance Officer, Regulatory Specialist, Regulatory Analyst, Clinical Administration Officer, Clinical Research Assistant, Pharmacovigilance Officer, Regulatory Affairs Consultant, Regulatory Affairs Coordinator, Quality Control Officer, Program Support Officer, Environmental Policy Officer, Environmental Health and Safety Officer, and Policy Analyst.
Pathways
Please use our Pathways tool to search for pathway options.
Learning Outcomes
The graduate has reliably demonstrated the ability to:
- Apply regulatory theories, concepts, and methodologies to assess the role of regulatory affairs and optimize regulatory processes and practices.
- Assess the roles and responsibilities of regulation professionals in lifecycle management of hazardous products.
- Interpret legislation, regulations and standards in Canada and the jurisdictions of significant trading partners to support international cooperation and harmonization.
- Assess and establish compliance with legislation and regulation by applying compliance promotion and enforcement policies and post-market surveillance techniques consistent with professional standards.
- Prepare and evaluate regulatory submissions and supplemental documentation requirements for pharmaceuticals, medical devices, agrochemicals, and industrial chemicals throughout their lifecycle.
- Analyze scientific and socioeconomic data to inform government, industry and other stakeholders of risk assessment and management approaches and strategies.
- Anticipate impacts of government regulations on product design and economics in industry to support risk management strategies.
- Assess information needs and analysis methods in science and socioeconomics to inform government decision-making for regulatory design and approval.
- Apply collaborative project management principles, leadership techniques and effective communication to implement and improve systems for regulatory compliance in government and industry.
- Organize and compose communications for public policy, public risk communications, consultations, and regulatory compliance to inform and mobilize risk avoidance actions for organizations and the public.
- Identify and apply discipline-specific practices that contribute to the local and global community through social responsibility, economic commitment, and environmental stewardship.
Tuition & Fees
2025/2026 Academic Year
Fees are subject to change.
Fees for part-time programs are charged on a course-by-course basis and are published on each individual course page. For questions related to fees, please call the Registrar's Office at 613-727-0002.
Graduation Fee
Once you have completed all the courses in the program, it is the responsibility of the student to complete a credential application (https://www.algonquincollege.com/online/certificationgraduating/). A graduation fee is charged when the application is submitted. After your credential application has been approved, you will be invited to Convocation.
Additional program related expenses include:
Books and supplies cost approximately $300. For more information go to www.algonquincollege.com/coursematerials
Admissions Requirements
Program Eligibility
- Ontario College Advanced Diploma, Degree or equivalent.
- Applicants with international transcripts must provide proof of the subject specific requirements noted above and may be required to provide proof of language proficiency. Domestic applicants with international transcripts must be evaluated through the International Credential Assessment Service of Canada (ICAS) or World Education Services (WES).
- IELTS -International English Language Testing Service-Overall band of 6.5 with a minimum of Reading: 6.0; Listening: 6.0; Speaking: 6.0; Writing: 6.5; OR TOEFL-Internet-based (iBT)-overall 90, with the minimum in each component: Reading: 22; Listening: 22; Speaking: 22; Writing: 24; OR Duolingo English Test (DET) Overall 120, minimum of 120 in Literacy and no score below 105.
Application Information
REGULATORY AFFAIRS - SCIENCES
Program Code 1523X07PAO
This program requires an application process.
Applications to graduate certificate part-time programs must be submitted via our online application form available at https://www.algonquincollege.com/online/part-time-graduate-certificate-application-form/
Prior to starting your application, please ensure that you have consulted the program admission requirements and have all the supporting documentation in a digital format ready to be uploaded.
Applications submitted in a paper format or via email will not be accepted and incomplete applications will not be processed.
Applications will typically be processed within 2-3 weeks, but can take longer during peak times and start of academic terms. Applicants are encouraged to apply at least 4-6 weeks prior to start of term.
Additional Information
Program Resources
International students wishing to study online should visit https://www.algonquincollege.com/online/international for information related to International online students and for International fees information prior to registering. Please note that AC Online programs do not qualify international students for new study permits or study permit extensions.
While admission requirements specify that an Ontario College Advanced Diploma is required for entry into the program, please be advised that most government and some industry positions require a degree. In particular, a B.Sc. is required by government agencies, such as Health Canada. Interested applicants should explore the minimum credential requirements for the career in their desired sector.
AC Online students will be required to complete a capstone project in the final course Regulatory Affairs Applied Project (RGL3900).
Graduates with degrees are encouraged to apply for Federal Student Work Experience Program (FSWEP) opportunities.
PRIOR LEARNING ASSESSMENT AND RECOGNITION (PLAR):
Students who wish to apply for PLAR need to demonstrate competency at a post-secondary level in all of the course learning requirements. Evidence of learning achievements for PLAR candidates may include a comprehensive challenge examination and/or completion of a portfolio.
AC ONLINE ACADEMIC PLANNER:
The Academic Planner provides registered part-time students in AC Online the ability to declare into a program of study. The Academic Planner outlines successfully completed courses to date, as well as courses that need to be completed in order to meet graduation requirements. It is therefore, essential that all part-time students in AC Online declare to their program of study, allowing administrators to plan course offerings. This tool is available on ACSIS.
PROGRAM PROGRESSION:
As per policy AA39: Program Progression and Graduation Requirements when students are admitted to a program, they are assigned to the Program of Study that aligns with their start date. If a student takes a break for two or more consecutive terms the Program of Study is reset to align with the current version (when studies are resumed).
Contact
Future Students
For additional information, please contact our Customer Service Representative team at online@algonquincollege.com and they will direct you to the best person to answer your specific questions.
Current Students
For additional information, please reference the AC Online Circle of Care.