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
Open
Closed
Waitlisted
Start Term
Availability
Competitive?
Fall 2025
No
Winter 2026
No
Spring 2026
No
Schedule
Program Summary
Credential
Program Code
Area of Interest
Other Delivery Options
Eligible for Post-Graduation
Work Permit?
In this one-year 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 one-year 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
Courses
Read this before applying:
Applications for this full-time program must be submitted on Ontario Colleges. If you are interested in the part-time delivery of the program, please refer to the part-time program page for course-by-course registration. The courses take place entirely online and do not require you to come to campus. Without a set class time you can complete your assignments when it’s most convenient for you while following the course deadlines.
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 |
|---|---|---|---|
| Level: 01 | |||
| ENL2300 | 56.0 | Communication for Regulation ProfessionalsCommunication for Regulation ProfessionalsRefining writing skills is a lifelong endeavor, even for the most sophisticated professional writers. For regulation professionals, continuous improvement in science and policy written communications is vital for a successful career path. Students review the fundamentals of effective writing by completing short written pieces typical of the regulatory affairs profession, including fact sheets, briefing notes, short research reports, and public awareness communications. This course is part of a complete program of study, individual course registration is not available. | |
| RGL2300 | 42.0 | Law and Policy Governing Chemicals and Medical DevicesLaw and Policy Governing Chemicals and Medical DevicesRegulation professionals involved in the regulation of pharmaceuticals, medical devices, agrochemicals, and industrial chemicals must be able to identify and interpret government policy, legislation, regulations, and international agreements applicable to these products. Students survey these policies, laws, and agreements to interpret content, function, and relationships. Comparative methods are used to examine similarities and differences between Canada's policies, laws, and international agreements and those of significant trading partners. This course is part of a complete program of study, individual course registration is not available. | |
| RGL2400 | 42.0 | Science and Risk Assessment in RegulationScience and Risk Assessment in RegulationScience plays a vital role in the risk assessment and life cycle management of hazardous products. Students assess the evolution of scientific methods in risk assessment; data types used in risk assessments; data collection methods; data quality assurance procedures; and data analysis techniques. Case studies illustrate science's contributions to robust risk assessments. Students explore debates in risk assessment literature regarding the potential for innovation in scientific methods and technologies to improve assessments of current and emerging risks. This course is part of a complete program of study, individual course registration is not available. | |
| RGL2500 | 42.0 | Theories, Concepts and Definitions in RegulationTheories, Concepts and Definitions in RegulationRegulation theories, concepts, and definitions are foundational intellectual tools for regulation professionals. Students investigate how theories inform the study of regulation in the public interest. Essential concepts and definitions in the regulation of science are identified, explained, and applied by students. Case studies, class discussions and research reports are used to practice effective use of foundational tools in analysis and communications. This course is part of a complete program of study, individual course registration is not available. | |
| RGL2600 | 56.0 | Regulation Design and Approval Processes in GovernmentRegulation Design and Approval Processes in GovernmentUnderstanding how regulations are prioritized, designed, and approved by governments is essential for regulation professionals. Through a review of official documents and case studies, students analyze the features and stages of regulation design and approval processes. Students explore case studies illustrating how regulation design considerations vary for different harm reduction scenarios. Finally, students survey process and procedural requirements for approval of new and amended regulations in the Government of Canada. This course is part of a complete program of study, individual course registration is not available. | |
| RGL2800 | 56.0 | Pre-Market Regulatory ProcessesPre-Market Regulatory ProcessesMost national regulatory regimes require pre-market regulatory assessments and approvals for pharmaceuticals, medical devices, agrochemicals, and industrial chemicals. Students use official guidance documents to analyze these regulatory processes for each product category. Canada's pre-market regulatory processes are compared with major trading partners. Processes for new or modified uses of regulated products already on the market are also analyzed and compared. This course is part of a complete program of study, individual course registration is not available. | |
| Level: 02 | |||
| RGL3400 | 42.0 | Post-Market Surveillance, Analytics and MonitoringPost-Market Surveillance, Analytics and MonitoringPost-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 This course is part of a complete program of study, individual course registration is not available. | |
| RGL3500 | 56.0 | Managing Life-Cycle Reg.Compliance Submissions for Pharma and Medical DevicManaging Life-Cycle Reg.Compliance Submissions for Pharma and Medical DevicRegulation 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. This course is part of a complete program of study, individual course registration is not available. | |
| RGL3600 | 56.0 | Managing Life-Cycle Reg.Compliance for Agrochemicals and Industrial ChemicalsManaging Life-Cycle Reg.Compliance for Agrochemicals and Industrial ChemicalsRegulation 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. This course is part of a complete program of study, individual course registration is not available. | |
| RGL3700 | 42.0 | Regulation and Industry Product Development ProcessesRegulation and Industry Product Development ProcessesCompanies 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. This course is part of a complete program of study, individual course registration is not available. | |
| RGL3800 | 42.0 | Public Risk Communications and ConsultationsPublic Risk Communications and ConsultationsRegulation 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 This course is part of a complete program of study, individual course registration is not available. | |
| RGL3900 | 56.0 | Regulatory Affairs Applied ProjectRegulatory Affairs Applied ProjectDesigning 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 This course is part of a complete program of study, individual course registration is not available. | |
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
Tuition and related ancillary fees for this program can be viewed by using the Tuition and Fees Estimator tool at www.algonquincollege.com/fee-estimator
Further information on fees can be found by visiting the Registrar's Office website at www.algonquincollege.com/ro.
Fees are subject to change.
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 1523X09FAO
Applications to full-time day programs must be submitted with official transcripts showing completion of the academic admission requirements through:
ontariocolleges.ca
60 Corporate Court
Guelph, Ontario N1G 5J3
1-888-892-2228
Applications are available online at www.ontariocolleges.ca.
Applications for Fall Term and Winter Term admission received by February 1 will be given equal consideration. Applications received after February 1 will be processed on a first-come, first-served basis as long as places are available.
International applicants applying from out-of-country can obtain the International Student Application Form at https://algonquincollege.my.site.com/myac360/s/self-registration-page or by contacting the Registrar's Office.
For further information on the admissions process, contact:
Registrar's Office
Algonquin College
1385 Woodroffe Ave
Ottawa, ON K2G 1V8
Telephone: 613-727-0002
Toll-free: 1-800-565-4723
TTY: 613-727-7766
Fax: 613-727-7632
Contact: https://www.algonquincollege.com/ro
Additional Information
Program Resources
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 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.
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.