Program Overview

Pharmaceutical Regulatory Affairs & Quality Operations (RAQ)

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

Skills

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 in managing the review process

Work Experience

Optional Work Term

This program offers the option to complete a work term, providing valuable hands-on experience in your field of study. Students interested in completing a work term should apply to the Pharmaceutical Regulatory Affairs & Quality Operations (Work Term) (RAQC) program.

Students who select the work term stream will have the opportunity to participate in a work term(s) if eligibility requirements are maintained. Students will have the flexibility to transfer to the non-work term stream at any time. The work term(s) is similar in length to an academic semester and is typically a full-time position that may be paid or unpaid. The work term job search is student-driven and participation in the work term stream does not guarantee that a work position will be secured. However, students will receive guidance and support through in-class career workshops and one-on-one coaching to help prepare for the work term.

Program Availability

• Canadian Applicants
• International Applicants

Start in | Location | Availability ---|---|--- Start in Sept. 2025 | Location Seneca@York | Availability _ _ Open Start in Sept. 2025 | Location Online | Availability _ _ Waitlist Start in Jan. 2026 | Location Seneca@York | Availability _ _ Open Start in Jan. 2026 | Location Online | Availability _ _ Open Start in May 2026 | Location Online | Availability _ _ Open

Availability is subject to change and a seat is not guaranteed.

Program and Course Delivery

This program is offered online, with some courses available in Seneca's flexible delivery format. In courses delivered in the flexible format, using interactive learning spaces, professors teach in person to students in a physical classroom or lab and stream to students online at the same time. Students have a choice of coming to campus for an in-person experience or learning online.

Your Career

When you graduate from this program, these are the types of career options you can explore:

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

Affiliations/Associations

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