About Our Company:

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, daring 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 build a strong culture of collaboration and partnership by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely crafted 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 is an excellent place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking bold actions to address some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Summary of Position:

As the Regulatory Affairs Clinical Trials Associate, you will conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance. Support the delivery of optimal Health Canada approvals (time and quality) and product labelling (packaging artwork) while maintaining compliance and maximizing a product’s potential and lifecycle in the Canadian marketplace.

What You’ll Do:

• Prepare, file, and review assigned CTA and related submissions, ensuring quality and compliance with Health Canada and AstraZeneca standards, including electronic Trial Master File requirements.
• Prepare, submit, and address issues to secure approvals for CTAs and related life-cycle submissions.
• Lead and support the submission review process, including responding to clarifaxes.
• Provide regulatory input and consultation to Canadian Cross-Functional Teams and Global Clinical and Regulatory teams to develop clinical trial strategies, ensure efficient Health Canada approvals, maintain compliance, and enhance the product portfolio and clinical R&D in Canada.
• Support the team in enhancing efficiency, performance, and productivity.
• Assist in developing and implementing regulatory strategic plans, including Regulatory Strategy Documents for novel trials with registration intent as needed.
• Assist in preparing for and leading pre-CTA meetings with Health Canada, collaborating with Key External Experts, participating in advisory meetings, and authoring summaries for Health Canada submissions as required.
• Assist with submission and negotiation of approvals for other regulatory submissions as assigned.
• Provide relevant information to support global clinical trial development and (investigational) product strategies, representing the Canadian market to mitigate regulatory risks.
• Ensure regulatory submissions and documents align with HPFB and AstraZeneca standards, including electronic submission processes.
• Participate in and comment on emerging Canadian regulations, policies, guidelines, initiatives, and surveys.

What We’re Looking For:

• 1-3 years of regulatory experience in the pharmaceutical or biotechnology industries.
• At least 1 year of regulatory project management experience.
• B.Sc. or equivalent in a related health science field; an advanced degree (e.g., M.Sc. or Ph.D.) is a plus.
• Familiarity with Canadian regulatory environment, regulations, policies, and guidelines.
• Experience with clinical trials and regulatory applications in key therapeutic areas.
• Excellent time management and organizational skills for balancing multiple projects and priorities.
• Detail-oriented with the ability to identify errors.
• Strong written and verbal communication skills.
• Positive interpersonal skills and ability to build relationships, working effectively within teams both internally and externally.
• Knowledge of international regulatory activities and trends.
• Proficient presentation skills.
• Strong negotiation, problem-solving abilities, and innovative, creative thinking.
• Ability to identify risks and develop plans to mitigate them.

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

At AstraZeneca, we are committed to investing in our employees' growth and development. Our strength lies in our global, diverse network. We work seamlessly together, adapting and learning together to find new solutions that accelerate our impact. We value wellbeing and flexibility, creating an environment where everyone feels at home from the moment they join. We are trusted partners across the enterprise, driving growth through our niche expertise.

Ready to make an impact? Apply now to join our team of specialists that is valued and essential to the growth of AstraZeneca!

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 AZCHumanResources@astrazeneca.com (mailto:AZCHumanResources@astrazeneca.com).

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.