Labeling Strategy Director

About the roleThe Labelling Strategy Director provides regulatory labellingexpertiseand guidance, typically for more complex drug projectsand across a Therapy Area(TA)/Disease Area(DA),toGlobal Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET)andcross functional Product Labelling Teams (PLT).TheLabelling Strategy Director responsibilities will be aligned toaTAand/orDA, andthis individualwill contribute todeveloping and shaping the strategic directionof the labellingcomponentof theregulatory strategyfor complex projects and/or disease individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. The individualhas a key role inthedevelopment of the labelling group by sharing knowledge and mentoringpeers,andsupportsand advisesthe respectiveSenior Director Group Manager (SDGM)toensureappropriate projectand Labelling Strategy Directorwill coach ormayserve as a line manager forLabellingmembers in the group andin conjunction withSDGMwillbeinvolved inhiring, training, coaching, and career development of staff. Ensures that the labelling process is followed through the lifecycle of the product.Ensure all work is performedin accordance withestablished procedures, regulatoryrequirementsandGxPs.Leads the development of the labelling strategy, in line with the overall regulatory strategy for the productand/or the disease area, by interpretation of regulations, guidance and competitor analyses,anticipatingand communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio. Leads the PLT in the preparation and maintenance ofhigh qualityCore Prescribing Information(CPI), EU Quality review of Documents (QRD), US Prescribing Information (PI), InstructionsForUse (IFUs) through to Senior Leader approval with the aim of achievingadvantageouslabelling. Leads the development of labelling negotiation strategies,anticipatingHA perspectives.Provides labellingexpertiseto the GRST/GRET/PLT for assigned productsand/oracross thedisease arearegardinglanguage,placementand regulatory content detail for CPI and MPI in line with company procedures, regional labellingregulationsand guidance.Provides clarityregardingapplicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.Evaluates,interpretsand communicates global regulations and trends on labelling and any business impact these might have on product labelling.Ensuresappropriate communicationacrossLabelling subfunctions.Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making. Leads the development of target labelling documentsand supportsother Labelling Strategists in the TAasappropriate.Assistin the development of labelling policies,proceduresand SOPs.Is a visible, approachable leader and role modelwithin andoutside ofLabelling teams.Coach ormay lead a team of Labelling members,providing guidance and support to the individuals as required depending on their level of experience to ensureappropriate Labellingsupport across allallocatedprojects.Effectively deputise for theSDGMasrequired.Required ExperienceUniversity Degree in Science or related discipline3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labelling Knowledge of labelling regulations andguidancesExcellent verbal and written communication skillsKeen attention to detail and accuracyMulti-cultural awareness and sensitivity;demonstratedexperience effectively communicating and negotiating in diverse cultures.Ability to assimilate clinical and scientific information and present it in a concise mannerAbility to think strategically, appropriately assess risks and formulate strategies to manage riskMustdemonstratecompetencies in:Building Relationships (works well across formal and informal networks) Negotiation Skills (good listener; able to build a consensus)Critical Information Seeking (works well across formal and informal networks)Rational Persuasion (able to distil an issue to its key components and suggest solutions)Interpersonal Awareness (aware of how actions affect other people)Desirable SkillsAdvanced academic training is highly desirable (PharmD, PhD)#LI-Hybrid Date Posted05-Jan-2026Closing Date22-Jan-2026