Conestoga College is a public college located in Kitchener, Ontario, Canada. It offers more than 200 programs in various fields such as Engineering, Business, Health Sciences, Information Technology, Media and Design, and Community Services.

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The regulatory affairs industry plays a critical role in ensuring the quality and safety of countless products and services, from pharmaceuticals, biologics and medical devices, to food and natural health products. Conestoga's program in Regulatory Affairs will prepare you for a career in a variety of regulated industries as a regulatory specialist, analyst, compliance officer, or quality assurance specialist. You will learn about the regulatory requirements established by various regulatory agencies and how they apply to the research, development, manufacturing, and marketing of new products and services. You will engage in experiential learning and acquire cutting-edge skills in developing an effective quality management system using real-world examples. You will examine the latest trends in regulatory affairs and learn essential skills to develop effective regulatory compliance strategies in a variety of industries and the health care sector. By building the knowledge and skills necessary to advance in the regulatory sector, you will enter a growing and dynamic industry and directly contribute to improving the well-being of our communities by ensuring the safety of products and services. Show less

Courses
Level 1
Course details
Conestoga 101
CON0101

Regulation Theory and Design
LAW8280

Project Management of Regulatory Submissions
MGMT8920

Regulatory Affairs and Quality Assurance Foundations
QUAL8390

Preparing Quality Regulatory Submissions
QUAL8420

Introduction to Clinical Research in Regulation
RSCH8180

Scientific Assessment and Data Analysis
RSCH8190

Level 2
Course details
Career Management
CDEV8132

Regulatory Submissions: Pre-Market
MGMT8950

Regulatory Submissions: Evaluation and Post-Market Analysis
MGMT8960

Strategic Planning and Regulatory Intelligence
MGMT8970

Quality Assurance in Regulation
QUAL8400

Regulatory Affairs Capstone
RSCH8200

Program outcomes
Design and develop processes and procedures that contribute to the creation of regulatory strategies related to a product's life cycle and ensure compliance to regulations.
Execute quality assurance and quality control processes to ensure conformance to Canadian, US and international harmonization standards and practices.
Prepare, manage and maintain regulatory packages and reports in compliance with industry-specific regulations and internal policies.
Use a wide range of data analysis methods to support decision making processes.
Manage and monitor change in regulations and their potential impacts on products or services and implement the respective corrective and mitigating strategies.
Conduct an industry and socio-economic impact analysis regarding the introduction of a new product, service 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 using regulatory intelligence and strategic vision
Participate in professional development activities to maintain currency in a changing regulatory affairs landscape.
Present technical information to a variety of stakeholders in accordance to regulatoryrequirements across the life cycle of a product or service

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You will need to book the accommodation after you have been accepted.

You can choose to live on campus or off campus in private accommodation.

How to book:

• Make a booking online after you have been accepted (in this case please let us know your choice when you apply).
• Register when you arrive - its not possible to reserve a room before arriving. You can arrive a few days before and book it

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