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?
Spring 2024
No
Fall 2024
No
Winter 2025
No
Spring 2025
No
Schedule
Program Summary
Credential
Program Code
Area of Interest
Other Delivery Options
The one year Regulatory Affairs - Sciences Ontario College Graduate Certificate program provides you with the skills and knowledge to pursue an entry-level career in industry and government regulatory agencies in Canada.
The regulation of products in industries such as healthcare, biotechnology, food, industrial chemical and agrochemical is of international concern. The resulting increase in regulation has driven the demand for qualified individuals in regulatory affairs....(read more)
Overview
Pursue a career in protecting the safety of people and the environment.
The one year Regulatory Affairs - Sciences Ontario College Graduate Certificate program provides you with the skills and knowledge to pursue an entry-level career in industry and government regulatory agencies in Canada.
The regulation of products in industries such as healthcare, biotechnology, food, industrial chemical and agrochemical is of international concern. The resulting increase in regulation has driven the demand for qualified individuals in regulatory affairs.
With a focus on protecting the safety of people and the environment, professionals in this field have a positive impact on the public good.
Understand the regulatory environment in Canada, including the socioeconomic aspects of:
- regulations across industries
- how to interpret and apply regulations
- how to develop and manage regulatory submissions
Learn project management and communications skills, and assess regulatory compliance and the frameworks that govern processes and products.
Graduates of this program have a strong understanding of regulation generally, but develop a detailed understanding of regulation for protecting public, worker and environmental health and safety in the areas of:
- pharmaceuticals and medical devices
- agrochemicals
- industrial chemicals, including in manufacturing and consumer products
You may also find employment in positions such as:
- quality assurance specialist
- administrator in various regulated industries
- analyst
- associate
- consultant
- regulatory compliance officer
SUCCESS FACTORS
This program is well-suited for students who:
- Possess strong written and oral communication skills.
- Are adept at analytical and critical thinking, and are detail-oriented.
- Are inquisitive and able to analyze, evaluate and apply relevant information from a variety of sources.
- Effectively conduct research and analyze findings.
- Possess effective leadership skills.
- Have a strong interest in protecting the safety of people and the environment.
Courses
Registration Note:
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.
Online  |
| Course Number | Hours | Course Name | Summer | |||
|---|---|---|---|---|---|---|
| Level: 01 | ||||||
| MGT4501 | 56.0 | Project ManagementMGT4501 Project ManagementProject management and leadership skills are critical for professionals in both the public and private sectors. Students investigate principles, tools and techniques of project management and learn to mitigate common issues to ensure project success and stakeholder satisfaction. Through case studies and team work, students explore leadership and team dynamics. This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL2000 | 42.0 | Governance and Policy InstrumentsRGL2000 Governance and Policy InstrumentsAn understanding of the regulatory framework in Canada and familiarity with international regulatory regimes is of paramount importance to professionals in regulatory affairs. Students examine and discuss legislation, policies and acts that shape regulations in Canada, and explore the relationships between regulations and policy instruments available to government. Using case studies, students situate regulations in the wider framework of governance across various sectors. Students work independently and in small groups to research, summarize and present comparisons of different regulatory regimes internationally and discuss the history, scope and potential impacts of the harmonization of those regimes. This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL2100 | 42.0 | Regulation TheoryRGL2100 Regulation TheoryRegulatory professionals must understand the role of regulation in serving the public interest. Students explore the purpose and impact of both pre- and post-market regulations, examine risk management strategies and discuss the roles of regulatory professionals. Through case studies and discussion, students develop a sound understanding in regulation theory and both the ethical and socioeconomic implications of regulatory practice. This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL2200 | 56.0 | Regulation DesignRGL2200 Regulation DesignThe design of a regulation has extensive implications for both government and industry stakeholders. Students explore performance-based and prescriptive regulations and discuss the impact on the roles and responsibilities of stakeholders, as well as concerns for compliance and enforcement. Students examine how patents, trademarks and copyrights relate to regulatory issues. Using case studies, students classify regulations, relate regulations to pertinent legislation and investigate the implications of a new or evolved technology, performance or process standard. This course is part of a complete program of study, individual course registration is not available. | | |||
| SCI4003 | 42.0 | Scientific Communication for Public PolicySCI4003 Scientific Communication for Public PolicyClear, concise and effective communication is required for success in this industry. Students explore and apply industry-specific technical writing strategies, such as assessing scientific procedures and clearly articulating complex technological problems. Through written assignments, presentations and simulating briefing activities, students develop written and spoken communication skills essential for professionals in this sector. This course is part of a complete program of study, individual course registration is not available. | | |||
| SCI4100 | 42.0 | Science and Risk Assessment in RegulationSCI4100 Science and Risk Assessment in RegulationRisk assessment using scientific data is critical for making sound regulatory decisions. However, the science used to assess risk varies widely across industries. Students investigate how scientific data is used in different fields and compare the risk assessment strategies used in different industries. Using case studies, students explore the validity of claims supported by different types of scientific data and discuss how risk assessment leads to effective risk management. In addition, students enhance research skills and the ability to assess the credibility of sources. This course is part of a complete program of study, individual course registration is not available. | | |||
| Level: 02 | ||||||
| QUA3000 | 56.0 | Critical Data Analysis in RegulationQUA3000 Critical Data Analysis in RegulationRegulatory decisions require not only an understanding of statistical data and processes, but also the ability to think critically about their application. Students investigate how statistical information is used to make regulatory decisions, explore the type of statistical analyses that are most appropriate in the various regulatory sectors, and describe how regulatory methodology can affect risk mitigation, and compliance. Students apply basic statistical concepts to data and explain their utility in regulatory decision-making. Using published literature, students examine data to understand the design, accuracy, and effectiveness of studies for use in regulatory processes. Pre-requisites: SCI4100 This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL3000 | 56.0 | Socioeconomics of Regulation DesignRGL3000 Socioeconomics of Regulation DesignChanges to regulations often have far-reaching consequences for all stakeholders. Students examine the role of relevant risk-management and socioeconomic principles in the regulatory process. Using case studies, students analyze the impacts of regulatory changes, the use of cost-benefit analysis and propose impact-mitigating strategies. Working independently and in groups, students examine Regulatory Impact Analysis Statements (RIAS) and Strategic Environmental Assessments (SEA). Pre-requisites: RGL2100 AND RGL2200 This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL3100 | 56.0 | Regulatory ProcessesRGL3100 Regulatory ProcessesThe regulatory processes in the pharmaceutical, agrochemical and industrial chemical industries vary widely. Students explore the regulatory processes and the roles of regulatory professionals in these three key industries and investigate how the regulations impact product development. Students consider the life cycle components of regulations in each industry, including stakeholders, risk assessments and pre- and post-market perspectives. Students analyze the agrochemical sector in detail. Pre-requisites: RGL2200 This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL3200 | 84.0 | Pre-Market Regulatory SubmissionRGL3200 Pre-Market Regulatory SubmissionRegulatory submissions are critical components of the regulatory process for both government and industry. Students work with industry to complete a regulatory submission from one of the following areas: pharmaceuticals, medical devices, biotechnology, natural health products, agrochemicals and/or industrial chemicals. Students delineate the appropriate sequence and processes required for new product approval, including the selection of appropriate guidance documents. Pre-requisites: MGT4501 AND SCI4003 This course is part of a complete program of study, individual course registration is not available. | | |||
| RGL3300 | 42.0 | Submission Evaluation and Post-Market AnalysisRGL3300 Submission Evaluation and Post-Market AnalysisThe regulatory requirements for a new product continue beyond the regulatory submission, to its evaluation and continued regulatory control once the product is on the market. Students consider the submission approval process and investigate the regulatory concerns for products once they are on the market. Using case studies, students apply the regulatory requirements at various stages in the evaluation of a new drug submission and determine the factors that contribute to approval or rejection. Pre-requisites: MGT4501 This course is part of a complete program of study, individual course registration is not available. | | |||
COURSE DESCRIPTIONS
MGT4501 Project Management
Project management and leadership skills are critical for professionals in both the public and private sectors. Students investigate principles, tools and techniques of project management and learn to mitigate common issues to ensure project success and stakeholder satisfaction. Through case studies and team work, students explore leadership and team dynamics.
RGL2000 Governance and Policy Instruments
An understanding of the regulatory framework in Canada and familiarity with international regulatory regimes is of paramount importance to professionals in regulatory affairs. Students examine and discuss legislation, policies and acts that shape regulations in Canada, and explore the relationships between regulations and policy instruments available to government. Using case studies, students situate regulations in the wider framework of governance across various sectors. Students work independently and in small groups to research, summarize and present comparisons of different regulatory regimes internationally and discuss the history, scope and potential impacts of the harmonization of those regimes.
RGL2100 Regulation Theory
Regulatory professionals must understand the role of regulation in serving the public interest. Students explore the purpose and impact of both pre- and post-market regulations, examine risk management strategies and discuss the roles of regulatory professionals. Through case studies and discussion, students develop a sound understanding in regulation theory and both the ethical and socioeconomic implications of regulatory practice.
RGL2200 Regulation Design
The design of a regulation has extensive implications for both government and industry stakeholders. Students explore performance-based and prescriptive regulations and discuss the impact on the roles and responsibilities of stakeholders, as well as concerns for compliance and enforcement. Students examine how patents, trademarks and copyrights relate to regulatory issues. Using case studies, students classify regulations, relate regulations to pertinent legislation and investigate the implications of a new or evolved technology, performance or process standard.
SCI4003 Scientific Communication for Public Policy
Clear, concise and effective communication is required for success in this industry. Students explore and apply industry-specific technical writing strategies, such as assessing scientific procedures and clearly articulating complex technological problems. Through written assignments, presentations and simulating briefing activities, students develop written and spoken communication skills essential for professionals in this sector.
SCI4100 Science and Risk Assessment in Regulation
Risk assessment using scientific data is critical for making sound regulatory decisions. However, the science used to assess risk varies widely across industries. Students investigate how scientific data is used in different fields and compare the risk assessment strategies used in different industries. Using case studies, students explore the validity of claims supported by different types of scientific data and discuss how risk assessment leads to effective risk management. In addition, students enhance research skills and the ability to assess the credibility of sources.
QUA3000 Critical Data Analysis in Regulation
Regulatory decisions require not only an understanding of statistical data and processes, but also the ability to think critically about their application. Students investigate how statistical information is used to make regulatory decisions, explore the type of statistical analyses that are most appropriate in the various regulatory sectors, and describe how regulatory methodology can affect risk mitigation, and compliance. Students apply basic statistical concepts to data and explain their utility in regulatory decision-making. Using published literature, students examine data to understand the design, accuracy, and effectiveness of studies for use in regulatory processes.
Pre-requisites: SCI4100
RGL3000 Socioeconomics of Regulation Design
Changes to regulations often have far-reaching consequences for all stakeholders. Students examine the role of relevant risk-management and socioeconomic principles in the regulatory process. Using case studies, students analyze the impacts of regulatory changes, the use of cost-benefit analysis and propose impact-mitigating strategies. Working independently and in groups, students examine Regulatory Impact Analysis Statements (RIAS) and Strategic Environmental Assessments (SEA).
Pre-requisites: RGL2100 AND RGL2200
RGL3100 Regulatory Processes
The regulatory processes in the pharmaceutical, agrochemical and industrial chemical industries vary widely. Students explore the regulatory processes and the roles of regulatory professionals in these three key industries and investigate how the regulations impact product development. Students consider the life cycle components of regulations in each industry, including stakeholders, risk assessments and pre- and post-market perspectives. Students analyze the agrochemical sector in detail.
Pre-requisites: RGL2200
RGL3200 Pre-Market Regulatory Submission
Regulatory submissions are critical components of the regulatory process for both government and industry. Students work with industry to complete a regulatory submission from one of the following areas: pharmaceuticals, medical devices, biotechnology, natural health products, agrochemicals and/or industrial chemicals. Students delineate the appropriate sequence and processes required for new product approval, including the selection of appropriate guidance documents.
Pre-requisites: MGT4501 AND SCI4003
RGL3300 Submission Evaluation and Post-Market Analysis
The regulatory requirements for a new product continue beyond the regulatory submission, to its evaluation and continued regulatory control once the product is on the market. Students consider the submission approval process and investigate the regulatory concerns for products once they are on the market. Using case studies, students apply the regulatory requirements at various stages in the evaluation of a new drug submission and determine the factors that contribute to approval or rejection.
Pre-requisites: MGT4501
Careers & Pathways
Careers
Graduates are well positioned for a variety of entry-level employment opportunities in the regulatory affairs sector. Positions may include but are not restricted to regulatory affairs officers, associates, analysts and consultants, regulatory compliance officers and consultants, and quality assurance specialists and administrators in the various regulated industries. Depending on the type of prior industry experience and credentials held, graduates may rise into positions with increasing levels of responsibility.
Employment may be found in organizations of all sizes in both the public and private sectors.
Pathways
Please use our Pathways tool to search for pathway options.
Learning Outcomes
The graduate has reliably demonstrated the ability to:
- Optimize processes, practices and products by interpreting and assessing the role of regulatory affairs in the healthcare, food, agrochemical and industrial chemical industries.
- Relate the roles and responsibilities of regulatory professionals in industry and government to explain their purposes to stakeholders.
- Distinguish between Canadian and international regulatory environments to anticipate the results of international harmonization.
- Ensure compliance with established regulations and laws that govern processes and products as per Canadian policies and professional standards.
- Prepare and evaluate components of regulatory submissions and supplemental documentation for products within the pharmaceutical, medical devices, biotechnology, agrochemical or industrial chemical sectors.
- Evaluate a wide range of data analyses to support decisions in the regulatory process.
- Anticipate the potential impact of regulatory changes to provide risk-mitigating recommendations.
- Conduct socio-economic impact analyses regarding the introduction of new products or policies on relevant industries and society.
- Apply collaborative project management principles, leadership techniques and effective communication to ensure the timely and successful completion of projects.
- Identify and apply discipline-specific practices that contribute to the local and global community through social responsibility, economic commitment and environmental stewardship.
Tuition & Fees
2023/2024 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 https://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 115, minimums of 115 in Literacy and 90 in Production.
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.force.com/myACint/ 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
This program is also available on-campus via the School of Advanced Technology, Applied Science and Environmental Technology Department.
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.
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
For additional information, please contact AC Online at online@algonquincollege.com or 613-727-4723 ext. 3330.