International Associate Regulatory Affairs Director I

Job description

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 filings across international markets. Build, maintain and leverage positive relationships with marketing companies and cross-functional partners such as global operations, labeling, manufacturing, patient safety, and development teams. Lead and/or contribute to the planning, authoring and delivery of complex maintenance submissions from an international perspective and ensure operational rigor in document management and compliance. Regulatory Intelligence and Best Practice: Act as a subject matter expert on procedural and documentation requirements across regions and modalities; understand evolving regulatory frameworks and special designations; feedback applied learnings from international submissions to enable knowledge sharing, and maintain up to date regulatory intelligence; apply best practices when interacting with health authorities directly or via affiliates in a dynamic environment. Planning, Risk and Metrics: Develop and maintain submission delivery and content plans providing proactive status updates to collaborators; coordinate inputs and updates in project planning tools; anticipate and articulate resource needs; identify regulatory risks early and lead mitigation planning to protect timelines and approvals. Coaching and Continuous Improvement: Coach and mentor colleagues within the international regulatory organization; role‑model effective delivery for complex international submissions; seek and implement continuous improvement to streamline processes and increase efficiency. Essential Skills/Experience: • Relevant University Degree in Science or related discipline • Extensive regulatory experience within the biopharmaceutical industry, with 10+ years working with International markets including new MAAs, CLE’s, licence maintenance and labelling • Thorough understanding of drug development and International market Regulatory Frameworks • Thorough knowledge of drug development and regulatory submission processes including MAA roll-out, Clinical Line extensions and lifecycle maintenance • Strong project and stakeholder management skills • Highly developed interpersonal skills, leadership skills, including experience leading multi-disciplinary project teams • Working with Global functions and time zones and expert knowledge of International markets • Proven track record of management of detailed regulatory requirements for International market MAA’s, CLE’s and LCM activities across projects/products • 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 (eg MS Project, Office Timeline Pro) and document management tools including Veeva Systems • Ability to work independently and as part of a team • Influencing and collaborator management skills • Ability to analyze problems and recommend actions • Continuous Improvement and knowledge sharing focused Desirable Skills/Experience: • Great understanding of Global Regulatory processes and tools with in depth International markets experience. • Managed complex regulatory deliverables spanning various projects and products (across International & Global markets) • Experience of working with people from locations outside of India, especially in the International regions • Strong understanding of major global Health Authority procedures which have an impact on International reliance market strategies When we put