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Pharmaceutical Regulatory Affairs and Quality Operations

Available: Summer, Fall, Winter

Program Description

In this program, you'll gain a foundational understanding of the areas of regulatory affairs and quality operations. Through studies of regulatory compliance in Canada and in other areas of the world, you'll be prepared for occupations involving drug or medical device submissions and quality assurance functions and roles.

The first semester will provide you with the fundamentals required in both regulatory affairs and quality operations. Introductory level courses equip you for the work term placement, which occurs between semesters and gives you the opportunity to apply the knowledge learned in the first semester. Your work term provides you with valuable industry exposure.

The second semester will provide more detailed and specific exposure to the areas of regulatory affairs and quality operations.

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2 Semesters (1 Year)

Credential Awarded

Ontario College Graduate Certificate

Your Career

Focus your career by specializing in Pharmaceutical Regulatory Affairs and Quality Operations. With your one-year graduate certificate, you'll be prepared for a dynamic career as a regulatory affairs associate, regulatory affairs assistant, quality assurance associate, quality assurance investigator, documentation administrator or medical information associate in the pharmaceutical, biotechnological, veterinary, cosmetic and food industries.

Work-Integrated Learning - Optional

Optional Work Term

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.


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

Related Careers


This Seneca program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Advanced Education and Skills Development.

Admission Requirements

Program Eligibility

  • A recognized degree from an accredited institution in science with a focus on chemistry, biology or pharmaceutical studies
  • English proficiency at the postsecondary level.

Applicant Selection

  • Applicants will be invited to attend an orientation where they will complete the Pre-Admissions English test and applicant profile.
  • Applicants are ranked based on the strength of their Pre-Admissions English test and applicant profile.
  • Admission to this program is highly competitive. Only the top ranked applicants will be offered a seat in the program.

Additional Requirements

  • Pre-admissions English test - Cost $55
  • Applicant profile

Program Costs

Choose academic year:

Tuition – Domestic


Tuition – International


Book & Supply Costs


Please note: All costs are approximate, may vary by campus and are subject to change at any time without notice. Parking, locker and some mandatory incidental fees are among the charges not included in the figures above.

Program Details

The Degree and Credit Transfer Office provides a number of services for students continuing their education at Seneca, and for graduating students considering degree transfer options.

Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at various post-secondary institutions. Please refer to the Degree Transfer Guide for more information.

Transfer Credit may be granted for courses deemed equivalent to courses at Seneca that have been completed at recognized postsecondary institutions. Additional information is available online.

Please take a few moments to view Important Academic Dates for your relevant term.

Please select the curriculum from the Academic Year in which you started (or will be starting) your studies. An Academic Year begins in September and ends in August of the following year.


Need to know more about your application and/or the application process? Reach out to our admissions advisors for assistance.

416.491.5050 ext. 22840

Student Recruitment

Have questions about Seneca’s campuses, financial aid, student supports and more? Connect with one of our student recruiters for more information or to book a campus tour.

Additional Contacts
Financial Aid & Awards

Program Coordinator

Tom McLerie 416.491.5050 ext. 33245

Program Chair

Paola Battiston 416.491.5050 ext. 33760

Why Choose Seneca?

Passionate, expert faculty from a range of professions

Real-world learning experiences through paid and non-paid work opportunities

Curriculums developed in collaboration with industry advisory committees

A variety of credentials offered from certificates, diplomas, degrees, and graduate certificates

Opportunities to pathway to higher level credentials at Seneca and other universities in our transfer partnership network