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Seneca Polytechnic - Seneca at York Campus
The Pharmaceutical Regulatory Affairs & Quality Operations (RAQ) Program is a one-year graduate certificate designed to help students specialize in regulatory affairs and quality operations. It provides a foundational understanding of regulatory compliance in Canada and internationally, preparing graduates for careers related to drug and medical regulations, as well as quality assurance roles. The first semester focuses on core concepts, while the second semester offers more in-depth study of regulatory and quality operations. Throughout the program, students develop key skills such as understanding Canadian and international healthcare legislation, regulations, and guidelines; analyzing manufacturing processes and their regulatory impact; preparing regulatory submissions, including documentation for the Therapeutic Product Program; applying good manufacturing practices; and managing and negotiating within the regulatory review process. The program also offers an optional work term for students who meet the academic requirements. This work term, similar in length to an academic semester, provides practical, hands-on experience in the field. Students interested in this option must enroll in the work term stream (RAQC). While participation in the work term stream offers access to career workshops, one-on-one coaching, and job search support, securing a position is not guaranteed and is the responsibility of the student. Additional fees apply to the work term stream regardless of employment outcome. The work term may be completed in person, online, or in a hybrid format, depending on the employer.
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