Regulatory Affairs, Project Manager - Establishment Licensing

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 Project Manager for Establishment Licensing, you will be responsible for developing and executing strategies, managing risks, and implementing tactics for Establishment Licensing related to New Drug Submissions and Post-Approval Variations involving supply chain site introductions and alterations. You will also support the Regulatory Chemistry, Manufacturing, and Controls (CMC) team to secure optimal Health Canada approvals, maintain compliance, and enhance productivity.

What You’ll Do:

• Drive and implement strategies for Establishment License (EL) submissions to secure timely DEL approvals that align with business objectives.
• Prepare regulatory files in accordance with DEL Regulations for submission to Health Canada (HC).
• Lead and manage EL-related interactions, meetings, and negotiations, ensuring effective communication with HC to facilitate submission approvals.
• Ensure DEL registration compliance for all marketed and upcoming products, supporting timely importation and distribution in Canada.
• Monitor and respond to changes in the regulatory environment, including regulations, guidelines, and policies related to Establishment Licenses.
• Maintain a deep technical understanding of compliance and regulatory requirements for Establishment Licensing and supply chain changes to proactively manage risks.
• Oversee the preparation of submission-ready components for Establishment Licensing in new drug submissions and post-approval variations involving supply chain changes.
• Collaborate with local and global Regulatory CMC teams to ensure alignment between Establishment Licensing information and the regulatory CMC dossier.
• Lead efforts to continuously improve processes related to Canadian Establishment License requirements.
• Assess draft HC guidelines, legislation, and policies related to Establishment Licensing and supply chain changes.
• Establish networks and processes to share project insights and lessons learned with colleagues and other project/product teams.
• Provide additional support to the Regulatory CMC area as needed.
• Develop and maintain positive relationships with all stakeholders involved in the lifecycle management of products.
• Ensure adherence to departmental and company standard operating procedures and processes.

What We’re Looking For:

• Over 3 years of experience in regulatory, QA, or supply chain management in the pharmaceutical or biotechnology industries.
• B.Sc. in Chemistry, Engineering, Biology, or a related discipline; advanced degree (M.Sc. or Ph.D.) is a plus.
• Familiarity with Establishment License requirements and management of post-approval changes for biologic and small molecule products.
• Experience in risk identification and management.
• Strong understanding of DEL regulations, cGMP, CMC Regulatory, ICH guidelines, and the Canadian regulatory environment, including Health Canada policies.
• Knowledge of drug substance/product manufacturing processes and international regulatory trends.
• Excellent project and time management skills for handling multiple projects and priorities effectively across therapeutic areas.
• Exceptional communication skills, both written and verbal.
• Strong interpersonal skills and a customer-focused attitude.
• Proficiency in MS Office; experience with document management systems is advantageous.
• Ability to innovate, solve complex problems, and maintain high attention to detail.
• Demonstrated teamwork and collaboration abilities.

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).

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 authorisation and employment eligibility verification requirements.