Pharmaceutical Regulatory Affairs and Quality Operations

(Co-op)

Program Description

This program is intended to provide students with a basic understanding of the areas of regulatory affairs and quality operations. Students will be prepared for occupations involving drug or medical device submissions and quality assurance functions and roles. The issues of regulatory compliance in Canada and in other areas of the world will be dealt with.

The first semester will provide the student with the fundamentals required in both regulatory affairs and quality operations. Introductory level courses will prepare the student for the co-operative work term placement, which occurs between semesters. The co-operative work term placement will provide the student with an opportunity to apply the knowledge learned in the first semester. Experience gained will allow the student to be exposed to one of the many employment possibilities attainable upon graduation.

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

Admission Requirements

Program Eligibility:

• Applicants must have completed a three year science diploma or degree with a focus on chemistry, biology or pharmaceutical studies.
• English proficiency must be at the college/ university level.

Applicant Selection:

• All eligible applicants will complete a questionnaire and/or Applicant Profile that will be assessed for content, writing skills, writing effectiveness and style.
• 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.

Your Career

Graduates from this program may pursue careers in the areas of Regulatory Affairs and Quality Operations. Career options include the pharmaceutical, biotechnological, veterinary, cosmetic and food industries. Graduates will find employment as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates.

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 the student with the opportunity to secure a paid work term between academic semesters.

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

Curriculum

Contact Us