Job Description

Job Title: Regulatory Affairs Manager I Career Level: D Introduction to Role: Are you a regulatory specialist with project management capabilities Do you thrive in a dynamic environment and enjoy leading the end-to-end planning, coordination, and execution of assigned deliverables If so, we have an exciting opportunity for you! As a Regulatory Affairs Manager I at AstraZeneca, you will be responsible for regulatory affairs management, global labelling management and dossier management. You will be expected to work flexibly to deliver these varied accountabilities as assigned to you by your line manager or by the Lead Regulatory Project Manager (RPM) for your allocated GRET(s). Accountabilities: As a Regulatory Affairs Manager I, you will contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. You will provide regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Essential Skills/Experience: Relevant University Degree in Science or related discipline Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development Thorough knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Regulatory affairs experience across a broad range of markets Managed regulatory deliverables at the project level Experience of working with people from locations outside of India, especially Europe and/or USA Desirable Skills/Experience: Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and stakeholder management skills Ability to analyze problems and recommend actions Continuous Improvement and knowledge sharing focused When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\'s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\'re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca At AstraZeneca\'s Oncology R&D department, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. We\'re motivated by science, success and achieving our goals in a way that\'s novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve. Are you ready to step up, take ownership of your work, solutions for the business and your personal career development Apply now and join us in our mission to bring life-changing medicines to people.

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