Director International Regulatory Policy (International Regulatory Affairs) – Asia job opportunity at AstraZeneca.

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AstraZeneca Director International Regulatory Policy (International Regulatory Affairs) – Asia
Experience: General
Pattern: full-time
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degreeAssociate
loacation Malaysia - Petaling Jaya, Malaysia
loacation Malaysia - Pet..........Malaysia

Job Description This role is a strategic role with responsibility as international regulatory policy director focusing on the Asia Region (ex-China and Japan) and working closely with Senior Area Regulatory Director- Asia, International Policy & Intelligence Lead, 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 the Asia Regulatory Policy is responsible for driving the development of impactful regulatory policy and advocacy with primary focus in the Asia region and key international topics in cooperation with global, regional, local and functional experts.   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 guidances 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 L ead   or   manage   reg ulatory   policy   priority topics   as coordinated by the   Global Regulatory Policy   Team   / International Policy and Intellig ence 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,   and its metrics for performance   internally and externally   Support the   develop ment for   the International Regulatory Policy Training Capability Framework   within Asia   Establish the   international   CMC-RA Policy Framework   in collaboration with i nternational   CMC   RA     Represent AZ   International   Regulatory Affairs on selected external   International   Trade Association committees , with focus on Asia,   to ensure AZ   International   Regulatory views on key issues are   represented   Attend relevant external meetings/conferences , with focus in Asia,   to obtain relevant intelligence of value to the business and communicate effectively.   May   represent   AZ in external benchmarking o n advocacy business practices.   Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration   Contribute to the strategy, direction and efficient operation of the   immediate team and function .   ​ Education, Qualifications, Skills and Experience Essential 10 +   years   in global regulatory affairs, including international   regions   (Asia ,   Latin   America   and   Middle East & Africa)     U nderstand s   the role of external   policy and   advocacy   and connections to business goals   in the International Regions .   Demonstrated   expertise   in Regulatory   policy related matters , through Health Authority or Industry experience , and more specifically in   two   or more International Regions such as Asia, Eurasia,   Latin   America   and Middle East & Africa .   Working knowledge   of   AZ focused disease areas ,   new therapeutic modalities ,   CMC   & quality, and   cross-area topics.     Thorough understanding and application of the Drug Development and associated regulatory processes   globally and internationally .   Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and   labelling   negotiations would be a plus.   Working e xperience in   developing   and executing   new product strategies for   global and   international regions   across different therapeutic areas   A collaborative, entrepreneurial mindset—comfortable with ambiguity and adept at building from the ground up   Demonstrated   proficiencies   in critical thinking, critical influencing, innovation, initiative,   leadership   and excellent oral and written communication skills.   The ability to think strategically and critically and evaluate risks to regulatory activities.   C ollaborative and   able to   be building   consensus with p eers and leadership   ( a bility to influence upwards)   Strong oral and written communication skills   Exper ience   in knowledge management and digital information management ​ Desirable Experience working in Health Authority   Problem solving skills   Focus on delivery and results   Experience in new modalities   ie   antibody conjugates,   cell and gene therapy,   radiotherapeutics   Experience of   participating   in key industry   groups and policy   for especially within Asia   Excellent strategic influencing and negotiation   Experienced Regulatory Professional with   degree   in   scientific   discipline, typically pharmacy   and   biological science.   Experience   or aptitude   in using AI/Gen AI   within regulatory space   ​ Date Posted 08-Jan-2026 Closing Date 30-Mar-2026 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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