Labeling Strategy Director
About the role
The 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 areas.This 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 resourceplanning.The 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 Experience
University Degree in Science or related discipline
3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labelling
Knowledge of labelling regulations andguidances
Excellent verbal and written communication skills
Keen attention to detail and accuracy
Multi-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 manner
Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Mustdemonstratecompetencies 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 Skills
Advanced academic training is highly desirable (PharmD, PhD)
Great People want to Work with us! Find out why:
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This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both exciting and inspiring, and it’s what keeps us motivated every day.
Ready to make a difference? Apply now!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com (mailto:AZCHumanResources@astrazeneca.com).
We are using AI as part of the recruitment process
This advertisement relates to a current vacancy.
#LI-Hybrid
Date Posted
05-Jan-2026Closing Date
22-Jan-2026AstraZeneca 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.
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