Project Manager

Description:

At AstraZeneca, we foster a collaborative culture where innovation thrives, and employees are empowered to share knowledge, take bold actions, and drive sustainability. As a Project Manager in Regulatory Affairs, your primary role will be to engage with regulatory teams to ensure effective regulatory strategies, achieve Health Canada approvals, and maintain compliance, thus optimizing the potential and lifecycle of products in the Canadian market.

You will contribute to regulatory submissions, manage stakeholder communications, and work with cross-functional teams to lead and execute strategic plans that meet both business and regulatory needs.

Responsibilities:

• Lead and execute regulatory strategic plans, including developing Regulatory Strategy Documents.

• Prepare, submit, and negotiate regulatory submissions to align with business and regulatory needs.

• Plan and conduct Health Canada meetings and prepare Key External Experts.

• Review and approve promotional materials to ensure they meet regulatory standards.

• Coordinate responses to transparency requests (e.g., ATI, PRCI).

• Support clinical trial applications as required.

• Provide strategic regulatory and business insights to Brand and Launch Teams.

• Represent the Canadian regulatory environment in global product development discussions.

• Stay updated on emerging Canadian regulations and provide feedback on regulatory guidelines.

• Foster collaboration with AstraZeneca Canada, Global Regulatory Affairs, Key External Experts, and Health Canada.

• Mentor and provide support to junior staff, including associates and students.

• Ensure adherence to Good Regulatory Practice principles.

Qualifications:

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.

• Excellent written and verbal communication skills.

• Proficient in MS Office.

• Strong understanding of the Canadian regulatory environment and Health Canada guidelines.

• Ability to identify and manage regulatory risks.

Desirable Qualifications:

• Advanced degree (MSc or PhD).

• Knowledge of therapeutic areas, products, and brands.

• Experience with cross-functional teams in Commercial, Market Access, Medical, and Operations.

• Awareness of international regulatory trends.

• Strong presentation skills and business acumen.

What We Offer:

• A collaborative and flexible working environment that allows a balance of personal and professional life.

• Opportunity to contribute to sustainability efforts and global health challenges.

• Award-winning corporate culture, recognized as one of Canada’s top employers.

• A focus on employee growth, development, and wellbeing.

Additional Information:

• AstraZeneca is an equal opportunity employer and is committed to diversity and inclusion.

• Reasonable accommodation is available upon request for persons with disabilities during the recruitment process.