Pharmaceutical Regulatory Affairs and Quality Operations (RAQC)

Focus your career by specializing in this one-year graduate certificate program. You will gain a fundamental understanding of regulatory affairs and quality operations. Studies of regulatory compliance in Canada and internationally will prepare you for a career involving drug or medical regulations and quality assurance functions and roles. During the first semester, you will learn the fundamentals of regulatory affairs and quality operations. Your second semester will focus on more detailed exposure to the areas of regulation and quality operations. This program offers an optional work term(s), similar to the length to an academic semester, if you meet all the academic requirements.

Part-time option is available >

Students meeting all academic requirements may have the opportunity to complete an optional work term(s) in a formal work environment. The work term(s) is similar in length to an academic semester and typically involves full-time work hours that may be paid or unpaid. In programs with limited work term opportunities, additional academic requirements and a passing grade on a communication assessment may be required for eligibility. Eligibility for participation does not guarantee a work position will be secured. Additional fees are required for those participating in the optional work term stream regardless of success in securing a work position.

• Regulatory affairs associate
• Regulatory affairs assistant
• Quality assurance associate
• Quality assurance investigator
• Documentation administrator
• Medical information associate
  

• Understand Canadian and international drug and other health care legislation, regulations and guidelines
• Understand process, regulations and the impact of manufacturing
• Prepare submissions, including supplemental documentation, to the
• Therapeutic Product Program
• Understand good manufacturing processes
• Negotiating in managing the review process
  

• Canadian Association of Professional Regulatory Affairs (CAPRA)
• Drug Information Association (DIA)
• Pharmaceutical Sciences Group (PSG)
• Regulatory Affairs Professional Society (RAPS)