Job Description
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to Role:
As a Regulatory Affairs Operations Excellence (RAOE) Associate, you will work collaboratively with Local and Global Regulatory teams, as well as cross-functional teams, to provide comprehensive operational capabilities and support in the core RAOE functional areas of Regulatory Submission Enabling, Labelling, Compliance and Intelligence. Your role will be crucial in supporting the timely and high-quality preparation and delivery of Canadian submissions and optimization of product labelling in accordance with AstraZeneca standards and our local GxP Quality Management System (QMS). You will play an active role in enhancing team efficiency, performance, and productivity, while ensuring compliance with AstraZeneca's corporate responsibility policies.
What You’ll Do:
Regulatory Submission Enabling, support role in:
Triaging and processing Health Canada correspondence; entering data into the Global Regulatory Information Management System.
Creating and coordinating approval of required submission documents and forms.
Assisting local RAOE, TA and CMC teams (as required) during the preparation, review and approval of pre/post-market submissions to Health Canada.
Assisting with post-approval activities, including Health Canada outcome processing and final Product Monograph (PM) processing.
Regulatory Labelling and Artwork Management, support role in:
Aiding the development and implementation of product labelling/packaging changes.
Performing QC reviews of local PMs and product packaging artwork.
Ensuring adherence to Global Labelling Business Processes and Electronic Labelling system processes.
Preparing Annual Product Review (APR) reports for labelling/packaging changes as required by Quality Assurance.
Regulatory Compliance and Local QMS Processes, support role in:
Assisting with local GxP Compliance and QMS activities, including Quality Issues, CAPAs, self-assessment audits and BCP testing.
Supporting maintenance of local GRP procedural documents.
Regulatory Intelligence, support role in:
Monitoring and reporting on Health Canada’s submissions under review list and "What’s New" web platforms.
Additional Responsibilities:
Assist with vendor management and invoice processing.
Support local onboarding activities.
Aid in local product divestment/discontinuation activities.
Support local Regulatory TAs and CMC functional areas as required.
What We’re Looking For:
University degree in a related health science discipline or equivalent relevant experience.
1-2 years of related experience in a reputable pharmaceutical or biotechnology company.
Knowledge of the Canadian regulatory environment, including Health Canada Labelling regulations, policies, and guidelines.
Strong project management, time management and organization skills with the ability to manage multiple projects and priorities efficiently.
Familiarity with electronic labeling systems and document management systems.
Proficient in business and technical applications of computer systems, including MS Office, document management, and tracking systems.
Excellent written and verbal communication skills.
Strong attention to detail.
Customer-focused approach.
Collaborative team player with strong interpersonal skills.
Strong analytical skills and technological agility.
Effective relationship management skills.
Who We Are:
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 10 years
Top 100 Employers Award
Canada’s Most Admired Corporate Culture
Learn more about working with us in Canada
View our YouTube channel
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to Role:
As a Regulatory Affairs Operations Excellence (RAOE) Associate, you will work collaboratively with Local and Global Regulatory teams, as well as cross-functional teams, to provide comprehensive operational capabilities and support in the core RAOE functional areas of Regulatory Submission Enabling, Labelling, Compliance and Intelligence. Your role will be crucial in supporting the timely and high-quality preparation and delivery of Canadian submissions and optimization of product labelling in accordance with AstraZeneca standards and our local GxP Quality Management System (QMS). You will play an active role in enhancing team efficiency, performance, and productivity, while ensuring compliance with AstraZeneca's corporate responsibility policies.
What You’ll Do:
Regulatory Submission Enabling, support role in:
Triaging and processing Health Canada correspondence; entering data into the Global Regulatory Information Management System.
Creating and coordinating approval of required submission documents and forms.
Assisting local RAOE, TA and CMC teams (as required) during the preparation, review and approval of pre/post-market submissions to Health Canada.
Assisting with post-approval activities, including Health Canada outcome processing and final Product Monograph (PM) processing.
Regulatory Labelling and Artwork Management, support role in:
Aiding the development and implementation of product labelling/packaging changes.
Performing QC reviews of local PMs and product packaging artwork.
Ensuring adherence to Global Labelling Business Processes and Electronic Labelling system processes.
Preparing Annual Product Review (APR) reports for labelling/packaging changes as required by Quality Assurance.
Regulatory Compliance and Local QMS Processes, support role in:
Assisting with local GxP Compliance and QMS activities, including Quality Issues, CAPAs, self-assessment audits and BCP testing.
Supporting maintenance of local GRP procedural documents.
Regulatory Intelligence, support role in:
Monitoring and reporting on Health Canada’s submissions under review list and "What’s New" web platforms.
Additional Responsibilities:
Assist with vendor management and invoice processing.
Support local onboarding activities.
Aid in local product divestment/discontinuation activities.
Support local Regulatory TAs and CMC functional areas as required.
What We’re Looking For:
University degree in a related health science discipline or equivalent relevant experience.
1-2 years of related experience in a reputable pharmaceutical or biotechnology company.
Knowledge of the Canadian regulatory environment, including Health Canada Labelling regulations, policies, and guidelines.
Strong project management, time management and organization skills with the ability to manage multiple projects and priorities efficiently.
Familiarity with electronic labeling systems and document management systems.
Proficient in business and technical applications of computer systems, including MS Office, document management, and tracking systems.
Excellent written and verbal communication skills.
Strong attention to detail.
Customer-focused approach.
Collaborative team player with strong interpersonal skills.
Strong analytical skills and technological agility.
Effective relationship management skills.
Who We Are:
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 10 years
Top 100 Employers Award
Canada’s Most Admired Corporate Culture
Learn more about working with us in Canada
View our YouTube channel
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].
💡 Quick Summary
Seeking a career-building opportunity? The Regulatory Affairs Operations Excellence Associate (12 Month Contract) position is now open for candidates interested in the Operations Executive Jobs sector. This role in Mississauga offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.
