Director Regulatory Policy & Intelligence

Director Regulatory Policy & Intelligence - AstraZeneca

The International Regulatory Policy Director for LATAM is a strategic leadership role within the International Regulatory Policy & Intelligence team, partnering closely with the Senior Area Regulatory Director–LATAM, the International Policy & Intelligence Lead, regional Marketing Companies, and global/regional functions. The Director drives regulatory policy development and advocacy for LATAM and selected international topics, co-develops policy positions, coordinates stakeholder interactions, and implements policies regionally to enable impactful external engagement on AZ’s regulatory science priorities, disease areas of interest, new therapeutic modalities, CMC & quality, and cross-functional topics. The role provides a broad strategic view based on deep knowledge of LATAM and international regulatory environments, maintains and builds health authority relationships, influences proposed rules and regulations affecting AZ and the industry, leads implementation of changes to international strategies and processes resulting from new legislation or guidance, and coordinates AZ’s responses to key regulatory policy topics at LATAM, International, and Global levels. The Director also assesses legislative and environmental changes for their impact on product strategy and communicates relevant insights to International Regulatory Affairs (inRA) Strategy groups for onward communication to Global Project Teams. Would you like an even shorter version suitable for a posting headline or social media?

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 LATAM
• 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 LATAM, to ensure AZ International Regulatory views on key issues are represented 
• May represent AZ in external benchmarking on advocacy business practices. 

Essential Requirements

• 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 be building 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 LATAM
• 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

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.

Date Posted

11-mar-2026

Closing Date

28-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.