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, and its metrics for performance internally and externally 

• Support the development for the International Regulatory Policy Training Capability Framework within Asia

• Establish the international CMC-RA Policy Framework in collaboration with international CMC RA  

• Represents 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 on 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. 

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Education, Qualifications, Skills and Experience

Essential

• 10+ years in global regulatory affairs, including international regions (Asia, Latin America and Middle East & Africa)  

• Understands 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 experience 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. 

• Collaborative and able to build consensus with peers and leadership (ability to influence upwards) 

• Strong oral and written communication skills 

• Experience 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

Closing Date

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.