Associate Regulatory Affairs Director

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About the role

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 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 prevent The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading complex regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams working flexibly within and across regions on different phases of drug development to ensure the delivery of business objectives. Accountabilities/Responsibilities: • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. • Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: • Submission delivery strategy of all dossiers and all application types per market and /or region • Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, Periodic Safety Reports, etc.) • Use and share guidelines, when handling various applications and procedures, while operating in a highly dynamic environment. • Lead and / or contribute to the planning, preparation and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective. • Lead multi-disciplinary project teams. • Develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators. • Identify regulatory risks and communicate mitigations to appropriate member of cross functional teams. • Support operational and compliance activities for assigned regulatory tasks. • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group. • Contribute to process improvement. Minimum Requirements – Education and Experience • Relevant University Degree in Science or related discipline • Extensive regulatory experience (5+ years) within the biopharmaceutical industry, or experience at a health authority • Thorough Knowledge of drug development • Strong project management skills • Leadership skills, including experience leading multi-disciplinary project teams Preferred Experience • Knowledge of the Respiratory & Immunology therapy area. • Managed first wave Marketing Application and/or Life Cycle Management submissions • Managed complex regulato

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