Director Regulatory Policy & Intelligence LATAM

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 DirectorLATAM 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 AZs 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 AZs 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

• Leadormanageregulatorypolicypriority topicsas coordinated by theGlobal Regulatory PolicyTeam/International Policy and Intelligence lead
• Providekey regulatory procedural/ environmental adviceon assigned topics to key customers/stakeholderswithin internationaland Global including theRegulatory TAs Commercial MC regulatory R&D Operationsand CMO functions.
• Supportpreparation ofregulatory policydocuments includingposition statements reports draftpapersand presentation materials.
• Supportwith theoversight and managementofinternational policy and intelligencescorecard KPIsand its metrics for performanceinternally and externally
• Support thedevelopment forthe International Regulatory Policy Training Capability Frameworkwithin LATAM
• Establish theinternationalCMC-RA Policy Frameworkin collaboration with internationalCMCRA
• Represents AZInternationalRegulatory Affairs on selected externalInternationalTrade Association committees with focus on LATAMto ensure AZInternationalRegulatory views on key issues arerepresented
• MayrepresentAZ in external benchmarking on advocacy business practices.

Essential Requirements

• 10yearsin global regulatory affairs including internationalregions(AsiaLatinAmericaandMiddle East & Africa)
• Understandsthe role of externalpolicy andadvocacyand connections to business goalsin the International Regions.
• Demonstratedexpertisein Regulatorypolicy related matters through Health Authority or Industry experience and more specifically intwoor more International Regions such as Asia EurasiaLatinAmericaand Middle East & Africa.
• Working knowledgeofAZ focused disease areasnew therapeutic modalitiesCMC& quality andcross-area topics.
• Thorough understanding and application of the Drug Development and associated regulatory processesglobally and experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team andlabellingnegotiations would be a plus.
• Working experience indevelopingand executingnew product strategies forglobal andinternational regionsacross different therapeutic areas
• A collaborative entrepreneurial mindsetcomfortable with ambiguity and adept at building from the ground up
• Demonstratedproficienciesin critical thinking critical influencing innovation initiativeleadershipand excellent oral and written communication skills.
• The ability to think strategically and critically and evaluate risks to regulatory activities.
• Collaborative andable tobe buildingconsensus with peers and leadership(ability to influence upwards)
• Strong oral and written communication skills
• Experiencein knowledge management and digital information management

Desirable

• Experience working in Health Authority
• Problem solving skills
• Focus on delivery and results
• Experience in new modalitiesieantibody conjugatescell and gene therapyradiotherapeutics
• Experience ofparticipatingin key industrygroups and policyfor especially within LATAM
• Excellent strategic influencing and negotiation
• Experienced Regulatory Professional withdegreeinscientificdiscipline typically pharmacyandbiological science.
• Experienceor aptitudein using AI/Gen AIwithin 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

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.