Director, Labeling Strategy

AstraZeneca•Gaithersburg, MD

2d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Advanced academic training is highly desirable (PharmD, PhD)

Responsibilities

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.
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.
Shape labeling negotiation strategies, anticipate health authority perspectives and equip teams with clear rationales and risk mitigations to secure optimal outcomes.
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.
Bring clarity in complex situations by outlining applicable requirements, highlighting risks and proposing pragmatic mitigations for stakeholders.
Evaluate, interpret and communicate global regulations and labeling trends, translating them into business-relevant insights and actions.
Lead development of Target Product Labeling documents to align development plans and evidence generation with intended label claims.
Contribute to the development of labeling documents, policies, procedures and SOPs and ensure the labeling process is followed across the product lifecycle.
Ensure all labeling work is performed in accordance with established procedures, regulatory requirements and GxPs.
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.
Partner with the Senior Director Group Manager on project and resource planning and effectively deputize as required to maintain momentum and quality.