Regulatory Affairs - Sciences (Co-op and Non Co-op Version) at Algonquin College

Pursue a career in protecting the safety of people and the environment.

The 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.

Students also 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 version of the program are subject to availability.

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 a/an:

• 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.

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.

Learning Outcomes

The graduate has reliably demonstrated the ability to:

1. Optimize processes, practices and products by interpreting and assessing the role of regulatory affairs in the healthcare, food, agrochemical and industrial chemical industries.
2. Relate the roles and responsibilities of regulatory professionals in industry and government to explain their purposes to stakeholders.
3. Distinguish between Canadian and international regulatory environments to anticipate the results of international harmonization.
4. Ensure compliance with established regulations and laws that govern processes and products as per Canadian policies and professional standards.
5. Prepare and evaluate components of regulatory submissions and supplemental documentation for products within the pharmaceutical, medical devices, biotechnology, agrochemical or industrial chemical sectors.
6. Evaluate a wide range of data analyses to support decisions in the regulatory process.
7. Anticipate the potential impact of regulatory changes to provide risk-mitigating recommendations.
8. Conduct socio-economic impact analyses regarding the introduction of new products or policies on relevant industries and society.
9. Apply collaborative project management principles, leadership techniques and effective communication to ensure the timely and successful completion of projects.
10. Identify and apply discipline-specific practices that contribute to the local and global community through social responsibility, economic commitment and environmental stewardship.

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 (Academic) 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.