Download the TIPT Regulatory Affairs digital brochure to learn more about the program, course syllabus, and career options.
The Pharmaceutical Regulatory Affairs diploma is a program that provides a practical understanding of the regulatory approval and communication processes involving pharmaceutical and biotechnology drugs as well as natural health products and medical devices.
While the primary emphasis is on regulatory affairs as it applies in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drugs Administration (FDA), our students also learn the regulations in other major jurisdictions such as Europe, Japan and Australia. You will acquire knowledge of international health care system, health care legislation, procedures and practices for regulating the development, manufacture, quality assurance and marketing of health care products.
In just under one year, you can gain the specialized knowledge and practical skills for a lucrative and rewarding career helping to bring new pharmaceutical, biotechnology, natural health, and medical device products to both domestic and international markets. Graduates develop the expertise to work in this challenging area in a variety of roles across the pharmaceutical, biotechnology, medical device, food, cosmetics, natural product, nutraceutical, and other life-science industries.
Program Highlights
- eCTD workshops on real drug submissions
- Industry relevant training
- Training in Health Canada submissions
- Small classes optimizing interaction
- High employment placement
- High entry level salary
Foundation Module
The foundation module is designed to provide a general overview background in regulatory sciences such as the medical and biopharmaceutical concepts and introduce new concepts in pharmaceutical Regulatory Agencies, Regulatory Affairs, and Clinical Trials.
Core Module
This module provides training in pharmaceutical regulatory affairs including GMP, technical writing, documentation and project management required for a successful career. Emphasis will be placed on IND/NDA/NDS/ANDA/BLA.
Advanced Module
Industry based projects mimicking regulatory affairs careers including the development of protocols and standard documentation requirements for the pharmaceutical industry.
Examination & Continuous Assessment
Written, oral and practical examinations are mandatory at the end of the foundation and core modules. In the advanced module, assessment is based on dissertation and viva-voce. In addition, the overall grade is also based on continuous assessments encompassing GMP and GLP compliance, pharmaceutical documentation skills and interim quizzes.
A diploma in Pharmaceutical Regulatory Affairs is awarded upon successful completion of all three modules.
A unique and highly successful aspect of our program is our hands-on approach provides the opportunity for students to apply and integrate their knowledge in a ‘real-world’ work setting under TIPT’s IPE system. You will receive practical experience with actual submissions that have been approved by regulatory authorities. Throughout the program, various practical projects expose you to pharmaceutical industry submissions and lets you apply you skills and knowledge in a real-world work setting.
International students also complete a 12 week co-op internship as part of their program completion and graduation requirements.
Admissions Requirements
- Bachelor of Science degree (majoring in Biological, Applied or Health Science, Chemistry, Pharmacy, some areas in Life Sciences, or a related field) or a Canadian technology / life science college diploma
- Successful applicants must possess above average writing and communication skills
- All applicants are required to submit a one-page hand-written scientific summary on a given topic
- Internationally-educated individuals must have the equivalent of a Canadian Bachelor of Science degree, and have their qualifications evaluated by one of the following:
- Meeting the minimum requirements does not guarantee admission to the program
Program Fees
Discover the fee breakdown for Pharmaceutical Regulatory Affairs and how it translates into an investment into your career with our Pros vs. Costs overview.
Financial aid may available for those who qualify. Learn about OSAP & financing.
Schedule Options
Students can complete this program with the following scheduling options:
- Full-time: weekly daytime classes, completed in 40 weeks.
- Flex: full-time classes on evenings & weekends, completed in 40 weeks.
- Flex+: part-time classes over a longer duration.
From the Classroom to your Career
The career paths of our graduates lead them to high-paying jobs in various industries including pharmaceutical, biopharmaceutical, biotechnology, advanced-drug delivery, medical devices, food, cosmetics, natural product, nutraceutical and other life science industries.
Graduates of this program secure employment in positions such as a:
- Regulatory Affairs Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Officer
- Technical Writer
- Documentation Specialist