Regulatory Affairs Operations Excellence Associate (12 Month Contract)

About Our Company:
 

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]. 

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Annual base salary for this position ranges from 75,752.00 to 99,424.50.AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.