Associate Regulatory Affairs Director - Respiratory & Immunology

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 BlueSky Hub 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 prevention. What you'll do Working in the role as an Associate Regulatory Affairs Director (ARAD), you will lead the end-to-end planning, coordination, and execution of assigned regulatory procedures and submissions. With your knowledge and strong project management skills, you will be a key contributor to the regulatory submission strategy, identifying submission risks and opportunities, while leading complex regulatory applications and managing procedures through approval. In this role you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions making sure that the regulatory project delivery and process improvements are in line with business priorities. Your main accountabilities/responsibilities: 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. 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 and review of documents e.g., response documents, study protocols, Periodic Safety Reports and provide regulatory input. Lead multi-disciplinary project teams. Support operational and compliance activities for assigned regulatory tasks. Provide coaching, mentoring and knowledge sharing within the regulatory skill group. Contribute to process improvement. Identify regulatory risks and propose mitigations to appropriate member of cross functional teams. Essential for the role Relevant University Degree in Science or related field. Extensive Regulatory experience (3+ years) within the biopharmaceutical industry, or at a Health Authority, or other proven experience. Thorough drug development knowledge. Strong Project management skills including tools e.g. MS Project. Excellent written and verbal communication skills. Leadership skills, including experience leading multi-disciplinary project teams. Desirable for the role Knowledge of the Respiratory & Immunology therapy area. Managed first wave Marketing Applications and/or Life Cycle Management submissions. Managed complex regulatory deliverables across projects/products. Veeva Vault experience. Demonstrate a high ability to use digital tools and solutions, and have a broad working knowledge of emerging technologies e.g., Artificial Intelligence and Machine Learning. Great People want to Work with us! Find out why: Are you interested in working at AZ, apply today! 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 . Date Posted 22-May-2024 Closing Date 20-Jun-2024 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.

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