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Introduction to Regulatory Affairs and the Regulatory Affairs Profession

Regulatory Affairs or RA is a relatively new profession that has developed in response to increased legislation set forth by governments to protect public health, regulating the quality, safety and efficacy of products such as pharmaceuticals, veterinary medicines, medical devices, agrochemicals, cosmetics and natural health products. Companies responsible for the discovery, testing, manufacture and marketing of therapeutic products want to ensure that the products that they make are safe and can be produced for sale. Most companies, whether they are multinational pharmaceutical corporations or small biotechnology companies have a RA department, and those who don't generally rely on the advice of independent regulatory consultants to meet their legal obligations.

Advances in science and technology, and changes in political environments, the healthcare sector and economics in general, shape the dynamic and expanding scope of the RA professional. RA professionals play key roles in the development, approval and surveillance of safe and effective healthcare products worldwide, ensuring compliance with applicable laws and regulations. RA professionals are typically responsible for the presentation of documents to regulatory agencies, as well as the negotiations necessary to obtain and maintain marketing authorization for the products concerned. They provide strategic, legal, scientific, and technical advice throughout the product lifecycle, including input on restraints, requirements and options, making an important contribution to the success of a regulated therapeutic product.

The specific roles of RA professional vary, depending on the size of the company, the type of products, and where they are to be made, tested or sold.

Interested in entering the Regulatory Affair profession? Here are some useful links to read up on the Profession.

A Day in the Life of a Regulatory Professional

Take a look at some interviews conducted by the student relations committee with a variety of Canadian Regulatory Professionals. 

Advertising and Promotion and Labelling - Innovative Drugs Pharmacovigilance - Innovative Drugs and Biologics Regulatory Affairs - Generic Drugs
Regulatory Affairs - Innovative, Generic and OTC Drugs Regulatory Affairs - Natural Health Products Regulatory Operations and eCTD Publishing - Innovative Drugs
Cannabis - Regulatory, Quality Affairs and Compliance    

 Useful Tools for the new Regulatory Professional

Frequently Asked Questions

Click here for the 5 most frequently asked questions by Regulatory Affairs students.

Educational Institutions

The following sites are some educational institutions that offer regulatory affairs courses:

Recognized educational institution offering training and development courses to individuals planning to enter the field of regulatory affairs wishing to be added can contact the Student Relations Committee Board Lead:

CAPRA Committees and Student Volunteer Opportunities

To volunteer for a CAPRA committee, please contact the respective Board Lead.

Contact information for CAPRA committees and Board Lead can be found at: CAPRA/ACPR COMMITTEES

Regulatory Affairs Websites

Please see the following section of the CAPRA website for useful Industry links: http://www.capra.caen/students/links-and-resources

Comments and Questions

If you have any questions or comments for the Student Relations Committee please forward them to us through the Contact Page.