Pharmaceutical Regulatory Affairs and Quality Operations
|Duration:||2 semesters (1 Year)|
|Credential Awarded:||Ontario College Graduate Certificate|
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 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.
- A recognized degree from an accredited institution in science with a focus on chemistry, biology or pharmaceutical studies
- English proficiency at the postsecondary level.
- Pre-admissions English test - Cost $55
- Applicant profile
- 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 are be offered a seat in the program.
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.
- Canadian Association of Professional Regulatory Affairs (CAPRA)
- Drug Information Association (DIA)
- Pharmaceutical Sciences Group (PSG)
- Regulatory Affairs Professional Society (RAPS)
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.
Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at the following post-secondary institution(s):
|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 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.
|2014/2015 Academic Year|
|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|
|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|
|2015/2016 Academic Year|
|Biotechnology and Biopharmaceuticals|
|Product Formulation and Manufacturing|
|Introduction to Quality Assurance|
|Introduction to Pharmaceutical Regulatory Affairs|
|Technical Writing and Communication I|
|Co-op Professional Theory (co-op option only)|
|Co-op Work-Term (co-op option only)|
|International Regulatory Affairs and Harmonization|
|Quality Assurance II|
|Regulatory Affairs II|
|Co-op Professional Practice (co-op option only)|
|For more information, please visit our website at: http://biochem.senecacollege.ca.|
|Domestic Admissions Advisor:||Telephone: (416) 491-5050 Ext. 22840
|International Admissions Advisor:||Valentyna Gorodovych
Telephone: (416) 491-5050 Ext. 22432
|Registration & Records Advisor:|
Telephone: (416) 491-5050 Ext. 33006
|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