Regulatory Affairs and Quality Operations (Co-op)
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Program Overview
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.
Program Details
Program Code
RAQ1
Credential:
Ontario College Graduate Certificate
Duration
45 Weeks
Start Dates
Locations
Availability
Full Time Offerings
2024 September
London
Open
2024 September
Toronto
Open
2025 May
Toronto
Open
2026 May
London
Open
Your Learning Experience
RAQ1 is the 2-year version of this program available to international students only. RAQ2 is the 1-year version of the program available to both international and Canadian students.
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 Information
Graduates 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 Associate
- Regulatory Affairs Assistant
- Quality Assurance Associate
- Quality Assurance Investigator
- Documentation Administrator
- Medical Information Associate
- Health Policy Researcher
- Consultant
- Program Officer
Learning Outcomes
- Analyze, synthesize and apply provincial, federal, and international regulatory processes as they relate to pharmaceutical, food, cannabis, biotechnology and medical device products
- Execute quality assurance and quality control processes to ensure compliance to Canadian and global regulatory requirements
- Employ appropriate use of IT software and systems to document, compile, manage and save content and data specific to regulatory affairs projects
- Use 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 submissions
- Conduct an industry and socio-economic impact analysis regarding the introduction of a new product and/or 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 submissions
- Adhere to regulations when conducting pre-clinical and clinical studies of biological products
- Adhere to the use of appropriate communication conventions and tools when compiling and submitting regulatory affairs documents
- Apply strategies for personal and professional development to enhance performance and maintain currency within the industry in a Canadian context.
Admission Requirements
One of:
Ontario College Diploma, Ontario College Advanced Diploma,
Degree in a health or science related field.
OR
equivalent qualification from another institution as judged by
the College
OR
equivalent professional background and experience as judged by
the College
International Admission Equivalencies
Admission equivalencies for Fanshawe depends on your country of study. Please enter your location to see the requirements for your country below.
English Language Requirements
English Language Requirements
| Test | Score |
|---|---|
| TOEFL iBT | 88 |
| IELTS Academic | Overall score of 6.5 with no score less than 6.0 in any of the four bands |
| CAEL | Overall score of 70 with no score less than 60 in any of the four bands |
| PTE Academic | 59 |
| Cambridge English | Overall score of 176 with no language skill less than 169 |
| ESL4/GAP5 | Minimum grade of 80% in Level 9, 75% in Level 10 |
| Duolingo | Overall score of 120, with no score lower than 105 |
Recommended Academic Preparation
Recommended Academic Preparation
- Previous business or IT post-secondary education and/or training and/or work experienceApplicant Selection Criteria
Applicant Selection Criteria
Where the number of program eligible applicants exceeds
available spaces, the Applicant Selection Criteria for this program
will be:
1. Preference for Permanent Residents of Ontario
2. Receipt of Application by February 1st (After this date,
Fanshawe College will consider applicants on a first-come,
first-served basis until the program is full)
3. Achievement in the Admission Requirements
Courses
| Level 1 | ||||
| Take all of the following Mandatory Courses: | ||||
| CANS-6001 | Contemporary Canadian Society | 3 | ||
| Using a sociological lens, this course introduces students to the Canadian social landscape and key societal topics. Students will learn about Canada's history and the experiences of various ethnic, linguistic, and racial groups within the nation. Through understanding the myriad dynamics of culture, socialization, and oppression, students will gain critical insight and holistic understanding of Canadian contemporary society. Topics relevant to race, gender, class, and immigration will be examined in the context of increased equity, diversity, and inclusion initiatives within Canadian institutions. | ||||
| CANS-6002 | Citizenship & Immigration in Canada | 3 | ||
| What are the factors that have influenced Canada's ever-evolving immigration and citizenship policies and how do these factors influence us today? These are the two major questions that we will address in this course. In answering these questions, we will look at why immigration was central to Canada's nation-building, why there was backlash to immigration, and why World War II was a catalyst for change in Canadian immigration policies. Through understanding the past, we will learn about today's understandings of culture, society, politics, civic responsibility, and belonging in relation to Canadian citizenship and immigration. | ||||
| COMM-6046 | Canadian Workplace Communications | 3 | ||
| This course will introduce post-graduate level international students to communication within the Canadian workplace. Topics to be covered will include verbal, non-verbal and written communications, with a focus on cultural differences. In this course, students will learn how to create basic workplace messages (including social media), engage in workplace conversations, organize workplace meetings, and deliver informal presentations. Instruction will emphasize the importance of tone, audience, purpose, body language, word choice, and grammar in the Canadian context. Through group work, students will develop interpersonal strategies for common face-to-face workplace interactions. By the end of the course, students will be able to confidently engage in basic communication with co-workers, clients and customers in the Canadian workplace. | ||||
| DEVL-6035 | The Canadian Workplace | 3 | ||
| This course will teach post-graduate level students that are new to the Canadian workplace the fundamentals of job searching practices, the various processes related to applying to jobs, interview techniques and employer expectations when interviewing. It will also examine workplace culture and on-the-job expectations in order to be successful in Canada. Students will become familiar with their rights and employment standards in Canada, and specifically in Ontario. Students will be able to create targeted resumes for various levels of employment in Canada. Students will also be introduced to the importance and value of Equity, Diversity and Inclusion as it relates to workplace organizations. By the end of the course, students will have the necessary tool kit, including essential entry-level marketing documents and various resources to be successful, to begin their career journey in Canada. | ||||
| DEVL-6036 | Post-Secondary Learning in Canada | 3 | ||
| This course will prepare graduate-level international students for the learning environment in Canadian post-secondary institutions. Topics to be covered will include academic integrity, research methods and online learning. Students will learn to apply research, information evaluation and citation skills in addition to learning critical Academic Integrity principles. Students will also be exposed to common teaching and learning methods used in graduate certificate programs, including case-based learning, problem-based learning and experiential learning, and investigate relevant study skills and College resources that will support their learning and development Students will work individually and in groups, both in F2F and online learning environments, and will have ample opportunity for skill development that will support their success in future coursework. | ||||
| POLI-6001 | Canadian Government & Politics | 3 | ||
| Canada's governments and political systems are faced with the challenge of governing a diverse population who inhabit the second-largest nation in the world. Understanding those systems is key to living, learning and working in Canada. Students taking this course will learn the history and current status of Canadian political systems and leaders - from the foundations of the nation at Confederation to the policies and issues behind current government decisions. Students will understand the rights of citizens, the laws of the nation, the political parties that seek to govern us, our three levels of government, and how to engage with those levels for specific issues or needs. Throughout the course, students will learn how to find reliable Canadian media sources to develop the skills needed to critically analyse current issues and consider ways in which the political system could be improved - in part, by considering the policies and practices of other nations. | ||||
| HLTH-6051 | Canadian Health Care System | 3 | ||
| This course will introduce graduate-level international students to the Canadian health care system. Topics to be covered include the history of health care, provincial and federal roles and responsibilities, key health care occupations, provincial health insurance inclusion, and private health care in Canada. Students will also explore and debate current health care issues and trends. At the conclusion of the course, students will have the knowledge and skills to confidently navigate and access their provincial health care system for themselves and their families. | ||||
Tuition Summary
London
Toronto
*Total program costs are approximate, subject to change and do not include the health and dental plan fee, bus pass fee or program general expenses.