International Associate Regulatory Affairs Director I

AstraZeneca — India - Bangalore

Job Title: International Associate Regulatory Affairs Director I Global Career Level: E1 Role Type: Individual Contributor for International Markets About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. About the role Introduction to role: Are you ready to accelerate approvals across diverse international markets and bring life-changing medicines to patients faster? This permanent role, based in India, sits at the heart of our efforts to move complex, innovative products through registration with speed and precision—so no patient waits As International Associate Regulatory Affairs Director I, you will provide expert regulatory advice and project management within a high-performing team focused on tactical excellence and rapid delivery. You will work across our oncology portfolio partnering closely with global and regional regulatory leaders. You will manage end-to-end Marketing Authorisation Applications, Clinical Line Extensions and Life Cycle Management. Can you see yourself turning insight into action, removing barriers, and ensuring right‑first‑time submissions that translate science into approved medicines? Accountabilities: Apply expertise in International regulatory affairs to improve submission delivery strategies for assigned products and markets whilst leading the tactical delivery of dossiers for new MAAs, CLEs, and LCM applications and coordinating, review, and responses to Health Authority Questions. Build and implement shared international submission to speed up filings. Collaborate with directors and International Regulatory teams passionate about international regulatory affairs to align objectives and remove obstacles to rapid

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