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  • Pharmaceutical Regulatory Affairs and Quality Operations

    Pharmaceutical Regulatory Affairs and Quality Operations


Program Code:RAQC
Duration:2 semesters (1 Year)
Start Dates:Summer, Fall, Winter,
Start dates are subject to change
Credential Awarded:Ontario College Graduate Certificate

Program Description

In RAQC, 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 co–operative 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.

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 college level.

Applicant Selection:

  • All eligible applicants will be required to attend a mandatory orientation session where they will complete a $55 pre-admissions test, a questionnaire, and/or Applicant Profile. These assignments will be assessed for content, writing skills, writing effectiveness, and style. A pamphlet with your testing information is available here.
  • Applicant selection will be based on the assessment of the above assignments, academic credentials, and English proficiency.
  • In some instances, an interview may be required.

The Importance of Learning Skills:

Student success in college requires well developed learning skills (such as being able to work independently, participate in a team, be well-organized, develop good work habits, and show initiative). These skills are as important as prior academic achievement. While it is expected that applicants would have developed these skills through previous education and life experiences, Seneca offers support to assist students with further development of these important skills. Seminars, workshops and tutoring are available at Seneca's Learning Centres.


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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 such dynamic careers as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates in the pharmaceutical, biotechnological, veterinary, cosmetic and food industries.

School Guidelines

All students are required to follow guidelines, policies and procedures set down by the School of Biological Sciences and Applied Chemistry.

Affiliations and Associations

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

Co-operative Education

The co-operative education component provides you with the opportunity to secure a paid work term between academic semesters.

Job-related employment enables you to combine classroom skills and on-the-job training.

Co-op Model - September Start
Sept-Dec Jan-Apr May-Sept
Semester 1 Work Term Semester 2

Co-op Model - January Start
Jan-Apr May-Aug Sept-Dec
Semester 1 Work Term Semester 2

Diploma to Degree... and Beyond

Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at the following post-secondary institution(s):


University/CollegeDegrees Available
Davenport University• Any relevant Bachelor or Master of Business Administration

Important Academic Dates

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


Semester 1 Course Name Hrs/Wk
PBB814 Biotechnology and Biopharmaceuticals 4
PFM714 Product Formulation and Manufacturing 3
PQA711 Introduction to Quality Assurance 4
PRA700 Introduction to Pharmaceutical Regulatory Affairs 7
TWC713 Technical Writing and Communication I 3
CPP100 Co-op Professional Theory (co-op option only) 1
CWT100 Co-op Work Term (co-op option only)
Semester 2 Course Name Hrs/Wk
IRA815 International Regulatory Affairs and Harmonization 3
PEC715 Pharmacoeconomics 3
PQA811 Quality Assurance II 4
PRA800 Regulatory Affairs II 6
PCR901 Introduction to Clinical Research 3
CPP200 Co-op Professional Practice (co-op option only) 1

Contact Us

For more information, please visit our website at:
Admissions Advisors:
Domestic Admissions Advisor: Carsten Wuertz
Telephone: (416) 491-5050 Ext. 22803
International Admissions Advisor: Valentyna Gorodovych
Telephone: (416) 491-5050 Ext. 22432
Registration & Records Advisor:
  Diane Duerden
Telephone: (416) 491-5050 Ext. 33006
Program Contacts:
Student Advisor: Monica Russell
Telephone: (416) 491-5050 Ext. 33769
Program Coordinator: Tom McLerie
Telephone: (416) 491-5050 Ext. 33245
Co-op Coordinator: Zahra Hirji
Telephone: (416) 491-5050 Ext. 33218
Program Chair: Paola Battiston
Telephone: (416) 491-5050 Ext. 33760
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