Regulatory Affairs - Sciences
New for Fall 2016

Ontario College Graduate Certificate (11 courses) Part-time Online
Program Code: 1523X07PWO Academic Year: 2016/2017

This program is listed under the following fields of study:

Other Delivery Options

Full-time Online
Full-time On Campus

Our Program

This one-year Ontario College Graduate Certificate program provides students with industry-specific knowledge to enter and promote their careers in regulatory affairs. 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.

Students examine the vital role performed by regulations and regulatory professionals, and become familiar with the regulatory environment in Canada and its harmonization with international regulatory regimes. The socioeconomic aspects of regulation across affected industries are also considered. Students develop familiarity with quality operations and navigating the regulatory landscape and frameworks that govern processes and products. Through collaborative work and individual study, students interpret and apply regulations, develop and manage regulatory submissions, assess regulatory compliance and report findings. Students enhance their communication and project management skills throughout.

This program prepares graduates to work in the regulatory affairs sector in industry and government regulatory agencies in Canada. Graduates may find employment in a wide range of sectors such as healthcare, food, agrochemical and industrial chemical industries.

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.
  • Are well-organized and effective time-managers.
  • Possess effective leadership skills.
  • Have a strong interest in protecting people and the environment.

Your Career

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.

Fees & Expenses

Books and supplies cost approximately $300.

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 contact the Registrar's Office to obtain a certificate/diploma application. A graduation fee of $40 will be charged when the application is submitted. When your certificate/diploma application has been approved, you will be invited to Spring or Fall Convocation.

Admission Requirements

Program Eligibility

Ontario College Advanced Diploma, degree or equivalent required.

Applicants with International transcripts must provide proof of either:

  • IELTS - International English Language Testing Service-Overall band of 6.5 with a minimum of 6.0 in each band; OR
  • TOEFL-Internet-based (iBT)-overall 90, with the minimum in each component: Reading: 22; Listening: 22; Speaking: 22; Writing: 24.
Program Eligibility

Ontario College Advanced Diploma, degree or equivalent required.

Applicants with International transcripts must provide proof of either:

  • IELTS - International English Language Testing Service-Overall band of 6.5 with a minimum of 6.0 in each band, OR
  • TOEFL-Internet-based (iBT)-overall 90, with the minimum in each component: Reading: 22; Listening: 22; Speaking: 22; Writing: 24.


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 and the Canadian Food Inspection Agency. 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.

Substitutes and equivalencies for Fall 2016:

  • The course MGT4501 is not available this semester, MGT4104 is the equivalent.

Additional Information

For more information, please contact the Brian Carriere, Program Coordinator, at


Online:Online Learning   
HoursCourse NameWinter
Series: 01
MGT450160.0Project Management

MGT4501 Project Management

There are no classes currently scheduled for this course.

RGL200045.0Governance and Policy InstrumentsOnline Learning
RGL210045.0Regulation TheoryOnline Learning
RGL220060.0Regulation DesignOnline Learning
SCI400345.0Scientific Communication for Public PolicyOnline Learning
SCI410045.0Science and Risk Assessment in RegulationOnline Learning
Series: 02
QUA300045.0Critical Data Analysis in RegulationOnline Learning
RGL300060.0Socioeconomics of Regulation DesignOnline Learning
RGL310060.0Regulatory ProcessesOnline Learning
RGL320090.0Pre-Market Regulatory SubmissionOnline Learning
RGL330045.0Regulatory Affairs Project - EvaluationOnline Learning


MGT4501 Project Management

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 and explore the type of statistical analyses that are most appropriate in the various regulatory sectors. Students apply basic statistical concepts to data and explain their utility in regulatory decision-making. Using case studies, students use performance data to investigate the effectiveness of a regulatory framework for a manufacturing process.

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: 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.

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: MGT4104

RGL3300 Regulatory Affairs Project - Evaluation

Regulatory evaluation of a new product is rigorous and complex. Students work with an industry partner to review existing evaluations and apply these evaluation principles to complete the evaluation of a new product.

Pre-requisites: MGT4104