Director International Regulatory Policy and Intelligence (International Regulatory Affairs) – Asia

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About the role

Job Description This role is a strategic role with responsibility as international regulatory policy and intelligence director focusing on the Asia Region (ex-China and Japan) and working closely with Senior Area Regulatory Director (SARD) - Asia, International Policy & Intelligence Senior Director, Marketing Companies within the region, and regional and global functions. This role will be part of International Regulatory Policy and Intelligence Team.    The International Director for Asia Regulatory Policy and Intelligence is responsible for driving the development of impactful regulatory policy and advocacy with primary focus in the Asia regions and key international topics in cooperation with global, regional, local and functional experts. Also, will lead regulatory intelligence and legislation surveillance across the region, translating legislative developments and regulatory trends into strategic insights that enable to anticipate challenges, seize opportunities, and ensure our medicines reach patients across the region.   The Director provides a broad strategic view for regulatory policy issues based on in-depth knowledge of the internal and external regulatory environment in Asia and across key international topics. The Director will contribute to and co-develop policy positions including stakeholder interactions and help to implement these policy positions regionally, leading to more impactful external engagements for AZ’s regulatory science priority topics, disease areas of interest, new therapeutic modalities, CMC & quality, and cross-area topics.      The Director will be a major participant in articulating AZ’s consolidated view on key international and Asia Region regulatory guidance and regulations. This includes maintaining and developing key health authority relationships and being able to influence proposed rules and regulations that specifically impact AZ and ultimately the pharmaceutical industry. The incumbent can also lead implementation of changes to international strategy and processes due to significant regulatory environment changes (new legislation/guidance etc.) and can lead AZ’s response to key regulatory policy topics within Asia, and at Global and International Level.   The director will assess the impact of new legislative/environmental changes on product strategy and communicate relevant information to international Regulatory Affairs (inRA) Strategy groups for onward communication to Global Project Teams    The Director will have a major role interacting with other parts of the AZ organization that are influencing policy and legislation at local, regional, and global levels and developing advocacy plans for their areas of responsibility whilst capturing key KPIs and metrics.      The Director attends relevant external meetings or conferences of value to the business, and contributes to the overall strategy, direction and efficient operation of the function.  There will be an opportunity for the incumber to engage with Governments, trade associations, and other stakeholders on international policy issues and represent AZ in the relevant platforms externally.      Typical Accountabilities • Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead  • Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions.  • Support preparation of regulatory policy documents, including position statements, reports, draft papers and presentation materials.   • Support with the oversight and management of international policy and intelligence scorecard KPIs, 

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