Associate Director, Labeling Strategy

AssociateDirector Labeling Strategy

Introduction to role:

Are you ready to turn complex science into clear compelling product information that accelerates access for patients Do you want to guide early decisions that shape the label and the path to approval for high-impact medicines AsAssociateDirector Labeling Strategy you willcontribute tosettingthe direction for global product information across a leading respiratory and immunology portfolio. You will work across early and late-stage development to influence study design evidence generation and submission planstranslating scientific insight into labels that best reflect benefitrisk and clinical value. You will lead cross-functional teams steer negotiations with healthauthoritiesandcontributetobuildingcapability across the labeling community ensuring our work drives tangible outcomes for patients healthcare professionals and the business.

Accountabilities:

• Labeling Strategy Leadership: Define and drive the labeling strategy in line with the products regulatory strategy by interpreting regulationsguidanceand competitor labels;anticipatewider impacts and long-term consequences for the product and the broader portfolio.

• AdvantagedProduct Information: Lead Product Labeling Teams to prepare andmaintainhigh-quality Core Product Information (CPI) and EU/US Prescribing Information (MPI) through senior leader approval to deliveradvantageouslabeling.

• Health Authority Negotiation: Shape labeling negotiation strategiesanticipatehealth authority perspectives and equip teams with clear rationales and risk mitigations to secureoptimaloutcomes.

• Expert Guidance to Key Teams: Provide labelingexpertiseto teams on languageplacementand regulatory content for CPI and MPI in line with company procedures and regional labeling regulations and guidance.

• Clarity in Complexity and Risk Insight: Bring clarity in complex situations by outlining applicable requirements highlightingrisksand proposing pragmatic mitigations for stakeholders.

• Global Intelligence and Trend Scanning: Evaluateinterpretand communicate global regulations and labeling trends translating them into business-relevant insights and actions.

• Target Product Labeling: Lead development of Target Product Labeling documents to align development plans and evidence generation with intended label claims.

• Process Policy and SOP Stewardship: Contribute to the development of labeling documents policiesproceduresand SOPs and ensure the labeling process is followed across the product lifecycle.

• GxPand Compliance Ownership: Ensure all labeling work is performedin accordance withestablished procedures regulatoryrequirementsandGxPs.

• Leadership and Capability Building: Be a visible approachable leader and role model; coach or line manage labeling team members; support hiring training coaching and career development; ensure appropriate labeling support across all allocated projects.

• Portfolio Planning and Governance: Partner with the Senior Director Group Manager on projectand resource planning and effectively deputize as required to maintain momentum and quality.

Essential Skills/Experience:

• Bachelors degree in science or related discipline with1years of pharmaceutical experience to include regulatory and labeling experience

• Ability to assimilate clinical and scientific information and present it in a concise manner

• Knowledge of labeling regulations and guidance

• Excellent verbal and written communication skills

• Keen attention to detail and accuracy

• Ability to think strategically appropriately assess risks and formulate strategies to manage risk

• Multi-cultural awareness and sensitivity;demonstratedexperience effectively communicating and negotiating in diverse cultures

• Mustdemonstratecompetencies in building relationships negotiation skills critical information seeking rational persuasion interpersonal awareness

Desirable Skills/Experience:

• Advanced academic training is highly desirable (PharmD PhD)

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work atpaceand challenge perceptions.Thatswhy we work on average a minimum of three days per week from the office. But thatdoesntmeanwerenot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here you will help redefine what Regulatory can achieveworking with scientists clinicians dataexpertsand developers to shape strategy early in the lifecycle and keep momentum through approval and beyond. We combine science-led decision making with progressive solutions-oriented thinking to shorten development cycles and build the strongest possible labels. It is a collaborative low-barrier environment where curiosity is encouraged diverse perspectives areheardand kindness sits alongside ambition. Your leadership will influence critical choices guide teams throughambiguityand translate breakthrough science into labels that improve patient outcomes worldwide.

Step into this pivotal role and lead labeling strategies that change the course of medicinemake your move today!

The annual base pay for this position rangesfrom $135625 to $203437. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coveragein accordance withthe terms of the applicable plans.