Pharmaceutical Regulatory Affairs and Quality Operations

Program Description

This program is intended to provide students 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:

• Applicants must have completed a science 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.

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.

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.

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):

U.S.

Curriculum

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