Regulatory Affairs Operations Associate

2 weeks ago

Mississauga, Canada AstraZeneca Full time

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.

As a **Regulatory Affairs Operations Associate**, you will work collaboratively with Local and Global Regulatory teams and cross-functional teams to provide Regulatory operational and administration services to support preparation and delivery of timely and high quality Canadian submissions, development of optimal product labelling and maintenance of our local GxP Quality Management System (QMS).

**Responsibilities**:

- Support preparation and delivery of submissions to Health Canada.
- Support and collaborate with all aspects of regulatory labelling and artwork management processes.
- Support regulatory compliance and local QMS processes.
- Triaging and processing of Health Canada correspondence and entry into the Global Regulatory Information Management System.
- Crafting and coordinating approval of relevant submission documents and forms.
- Ensuring adherence to Global Labelling Business Processes and Electronic Labelling system processes.
- Supporting the development and implementation of product labelling/packaging changes as required by Regulatory Affairs, Marketing and/or Operations.
- Performing QC reviews of local Market Product Information (i.e. Product Monographs) and product packaging artwork.
- Overseeing local GxP records filing and archiving management process.
- Supporting local GxP Compliance management reviews, including coordination and compilation of GxP critical metrics and monitoring/reporting on Good Regulatory Practices (GRP) training compliance.
- Maintaining local GRP training curriculums.
- Supporting maintenance of local GRP procedural documents.

Other responsibilities may include:

- Supporting vendor management and invoice processing activities.
- Supporting local onboarding activities.
- Supporting local product divestment/discontinuation activities.
- Supporting Regulatory Operations Excellence initiatives and projects.
- Performing other activities as assigned.

**Essential Requirements**:

- Minimum 2 years of experience in Regulatory Affairs, Patient Safety and/or Quality Assurance within the brand name pharmaceutical or biotechnology industries would be an asset.
- Knowledge of the Canadian Regulatory environment and Health Canada regulations, policies and guidelines.
- Strong project management, time management and organization skills (ability to manage multiple project and priorities effectively).

**Desirable Requirements**:

- Experience with Good Manufacturing Practices (drug product manufacturing/packaging, change control management, etc).
- Knowledge of electronic labelling systems and information/document management systems.
- Business acumen, such as writing business proposals and project plans.

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

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