Associate Director, Labeling Strategy

AstraZeneca • Boston, MA

1d • Hybrid

About The Position

This role contributes to setting the direction for global product information across a leading respiratory and immunology portfolio. The Associate Director, Labeling Strategy 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. The individual will lead cross-functional teams, steer negotiations with health authorities and contribute to building capability across the labeling community, ensuring the work drives tangible outcomes for patients, healthcare professionals and the business.

Requirements

• Bachelor’s degree in science or related discipline
• 1 + 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.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level