Director International Regulatory Policy and Intelligence (International Regulatory Affairs) – MEA & Eurasia

JOB TITLE

Director International Regulatory Policy and Intelligence (International Regulatory Affairs) MEA & Eurasia

ABOUT ASTRAZENECA

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.

ROLE SUMMARY

This role is a strategic role with responsibility as international regulatory policy and intelligence director focusing on the MEA and Eurasia Region (EAEU Ukraine Moldova Georgia) and working closely with Senior Area Regulatory Director (SARD)- MEA SARD Eurasia 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 MEA and Eurasia Regulatory Policy and Intelligence is responsible for driving the development of impactful regulatory policy and advocacy with primary focus in the MEA and Eurasia 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 MEA and Eurasia 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 AZs 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 AZs consolidated view on key international and MEA and Eurasia 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 AZs response to key regulatory policy topics within MEA and Eurasia 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.

What youll do

• 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 MEA and Eurasia

• Establish theinternationalCMC-RA Policy Frameworkin collaboration with internationalCMCRA

• Represents AZInternationalRegulatory Affairs on selected externalInternationalTrade Association committees with focus on MEA and Eurasiato ensure AZInternationalRegulatory views on key issues arerepresented

• Attend relevant external meetings/conferences with focus in MEA and Eurasiato obtain relevant intelligence of value to the business and communicate effectively.

• MayrepresentAZ 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 theimmediate team and function.

Essential for the role

• 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 tobuildconsensus with peers and leadership(ability to influence upwards)

• Strong oral and written communication skills

• Experiencein knowledge management and digital information management

Desirable for the role

• 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 MEA and Eurasia

• Excellent strategic influencing and negotiation

• Experienced Regulatory Professional withdegreeinscientificdiscipline typically pharmacyandbiological science.

• Experienceor aptitudein using AI/Gen AIwithin regulatory space.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

• Are you already imagining yourself joining our team Good because we cant wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.

Where can I find out more

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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.