Director, Labeling Strategy

Director, 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? As Director, Labeling Strategy, you will set the 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 plans—translating scientific insight into labels that best reflect benefit–risk and clinical value. You will lead cross-functional teams, steer negotiations with health authorities and build capability 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 product’s regulatory strategy by interpreting regulations, guidance and competitor labels; anticipate wider impacts and long-term consequences for the product and the broader portfolio.
• Advantaged Product Information: Lead Product Labeling Teams to prepare and maintain high-quality Core Product Information (CPI) and EU/US Prescribing Information (MPI) through senior leader approval to deliver advantageous labeling.
• Health Authority Negotiation: Shape labeling negotiation strategies, anticipate health authority perspectives and equip teams with clear rationales and risk mitigations to secure optimal outcomes.
• Expert Guidance to Key Teams: Provide labeling expertise to teams on language, placement and 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, highlighting risks and proposing pragmatic mitigations for stakeholders.
• Global Intelligence and Trend Scanning: Evaluate, interpret and 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, policies, procedures and SOPs and ensure the labeling process is followed across the product lifecycle.
• GxP and Compliance Ownership: Ensure all labeling work is performed in accordance with established procedures, regulatory requirements and GxPs.
• 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 project and resource planning and effectively deputize as required to maintain momentum and quality.

Essential Skills/Experience:

• Bachelor’s degree in science or related discipline with 5+ years 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; demonstrated experience effectively communicating and negotiating in diverse cultures
• Must demonstrate competencies 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 medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not 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 achieve—working with scientists, clinicians, data experts and 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 are heard and kindness sits alongside ambition. Your leadership will influence critical choices, guide teams through ambiguity and translate breakthrough science into labels that improve patient outcomes worldwide.

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

The annual base pay for this position ranges from $186,233 to $279,349. Our positions offer eligibility for various incentives—an 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 coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.