Regulatory Affairs, Project Manager

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 a Project Manager in Regulatory Affairs, your role is to engage in activities that align with our Company values and adhere strictly to the Code of Conduct, as well as any relevant Policies and Standards. Ensure you complete all required training on the AZ Code of Conduct and its supporting Policies and Standards promptly. Be vigilant in identifying and reporting potential compliance issues.

Your responsibilities include providing regulatory input and direction to Brand and Global regulatory teams. This is critical to delivering effective regulatory strategies, achieving timely and high-quality Health Canada approvals, maintaining compliance, and optimizing the potential and lifecycle of our products in the Canadian market.

What You’ll Do:

• Lead the creation and execution of regulatory strategic plans, including developing Regulatory Strategy Documents.
• Evaluate, prepare, submit, and negotiate regulatory submissions to achieve optimal outcomes that align with cost recovery, business, and regulatory needs.
• Plan and conduct Health Canada meetings, preparing Key External Experts as well as Global and Local cross-functional teams.
• Develop and finalize Health Professional/Public Communications, as needed.
• Review and approve promotional materials and external communications to ensure they meet regulatory standards.
• Compile or coordinate responses to transparency requests, such as ATI and PRCI.
• Initiate and support artwork-related activities.
• Provide support for clinical trial applications when required.
• Provide strategic, informed regulatory and business expertise to Brand and Launch Teams, as well as across the organization.
• Influence global product development, representing the Canadian regulatory environment and market to mitigate regulatory risks in development plans where applicable.
• Ensure that all regulatory submissions and documents align with HPFB and AZ requirements and standards.
• Remain informed about and provide feedback on emerging Canadian regulations, policies, guidelines, initiatives, and surveys.
• Champion collaboration with AstraZeneca Canada, Global Regulatory Affairs, Key External Experts, and Health Canada to identify and leverage opportunities through thoughtful planning and action.
• Contribute to improving collaboration, efficiency, performance, and productivity within the Regulatory Affairs department.
• Provide guidance and support to junior staff members, including associates and students.
• Maintain adherence to Good Regulatory Practice principles and complete all required training on time.

What We’re Looking For:

Essential Qualifications:

• 3-5 years of regulatory experience in pharmaceuticals or biotechnology, preferably with brand name products.
• Bachelor's degree or equivalent in a health science-related field.
• Strong negotiation, project management, and organizational skills, with the ability to lead multiple projects effectively.
• Excellent written and verbal communication skills.
• Experienced in risk identification and management.
• Adept at building interpersonal relationships and collaborative teamwork.
• Strong problem-solving and critical think abilities.
• Thorough understanding of the Canadian regulatory environment and Health Canada guidelines.
• Proficient in MS Office.
• Customer-focused.

Desirable Qualifications:

• Advanced degree (MSc or PhD) is an advantage.
• Knowledge of therapeutic/functional areas, products, and brands.
• Awareness of competitor products.
• Cross-functional strategic knowledge in Commercial, Market Access, Medical, and Operations.
• Ability to take calculated risks.
• Familiarity with international regulatory trends.
• Strong presentation skills and business acumen, including writing business proposals and project plans.

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 authorization and employment eligibility verification requirements.