Associate Director, Labeling Strategy

Associate 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 Associate Director, Labeling Strategy, you will contribute to setting 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 contribute to building 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: