Ontario College Graduate Certificate of Regulatory Affairs and Quality Operations (CO-OP)

Companies that intend to develop and commercially distribute regulated pharmaceuticals and life-science products are required to have knowledge of the full spectrum of regulatory requirements in those industries. This program will provide students with the in-depth knowledge and hands-on training required to assist with navigating regulatory approval processes, primarily for pharmaceuticals, biotechnology, and medical devices with a secondary focus on food and herbal products. Students will specifically learn the process for developing successful regulatory applications that allow companies to proceed with the development and launch of new products.Students will develop the strong communication, negotiation, and project management skills necessary for the preparation of successful regulatory affairs applications and documentation. They will also practice their attention to detail and strategic thinking skills, all of which are critical for career progression within the highly competitive pharmaceutical and biotechnology industries. Students’ real-world experience is enhanced through a co-op work experience that is included in the program.Career InformationGraduates of this program will be prepared to secure positions with government departments and agencies, consulting establishments, universities, research​institutes, hospitals, community agencies, educational institutions, professional associations, non-governmental and international organizations in a variety of roles such as:Regulatory Affairs AssociateRegulatory Affairs AssistantQuality Assurance AssociateQuality Assurance InvestigatorDocumentation AdministratorMedical Information AssociateHealth Policy ResearcherConsultantProgram OfficerLearning OutcomesAnalyze, synthesize and apply provincial, federal, and international regulatory processes as they relate to pharmaceutical, food, cannabis, biotechnology and medical device productsExecute quality assurance and quality control processes to ensure compliance to Canadian and global regulatory requirementsEmploy appropriate use of IT software and systems to document, compile, manage and save content and data specific to regulatory affairs projectsUse a wide range of data analysis methods to support decision making processes.Apply project management and risk management principles to the successful completion of regulatory submissionsConduct an industry and socio-economic impact analysis regarding the introduction of a new product andor policy.Work collaboratively with product development teams, applying leadership techniques to complete projects in accordance with project timelines.Identify and apply regulatory strategies that contribute to and promote health equity in diverse communities.Examine the role of Canadian regulatory affairs professionals and participate in professional development activities to maintain currency in a changing regulatory affairs landscape.Adhere to the International Organization for Standardization (ISO), Therapeutic Products Program (TPP) and bioethical protocols and guidelines for drug, medical device, and biological product submissionsAdhere to regulations when conducting pre-clinical and clinical studies of biological productsAdhere to the use of appropriate communication conventions and tools when compiling and submitting regulatory affairs documents