Pharmaceutical Regulatory Affairs and Quality Operations

Program Overview:

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 of an academic semester, if you meet all the academic requirements.

Admission Requirement:

• Ontario university or college degree or equivalent in science with a focus on chemistry, biology or pharmaceutical

• Successful completion of postsecondary degree or diploma with 2nd class/division

• IELTS minimum 6.5 with no skill below 6.0

• PTE minimum score 60 in each band.

Program Outcomes:
Throughout this program, you will develop the following skills:

• 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 and managing the review process

Career Outlook:
Graduates of the program can explore the following career options:

• Regulatory affairs associate

• Regulatory affairs assistant

• Quality assurance associate

• Quality assurance investigator

• Documentation administrator

• Medical information associate

Tuition Fee: Click Here

Program Intake: Fall, Winter & Spring