JobMesh

Director, Labeling Strategy

AstraZeneca · Gaithersburg, Maryland, US

Director, Labeling Strategy Introduction to role: Are you ready to turn complex science into clear, compelling product information that accelerates access fo...

Job description

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: L...