Executive Director Global Labeling

Role Summary

The Executive Director, Global Labeling is a senior leadership role responsible for shaping and executing global regulatory labeling strategies to support company objectives and patient needs. This role leads a high-performing team of Labeling Strategists, ensuring timely, efficient, and compliant development and maintenance of labeling documents for US, EU, and international markets. The role oversees global labeling strategy, management, compliance, end-to-end labeling processes, policy, and cross-functional labeling office activities to optimize speed to patient.

Responsibilities

• Builds and leads a high-performing global labeling team, fostering a culture of excellence, accountability, and innovation
• Recruits, develops, and retains top talent, ensuring the team has the right mix of skills and experience
• Establishes clear roles, responsibilities, and career development paths to support team growth and engagement
• Translates strategy into operational goals, priorities, and plans; ensures Global Labeling is adequately staffed and trained to fulfill its function
• Influences internal and external stakeholders, including health authorities, to shape labeling outcomes
• Defines and establishes effective processes, SOPs, and work practices to drive consistency and efficiency
• Develops strong working relationships with key stakeholders within Global Regulatory Sciences, Drug Development, Medical, Global Product Development & Supply, and the broader organization
• Acts as a credible, influential spokesperson; externally focused and results-driven; optimizes unit deliverables for speed to patients
• Proactively manages Labeling Book of Work and monitors progress against submission timelines; prioritizes resources to meet company objectives
• Oversees continuous improvement of E2E Labeling initiatives to establish well-documented, optimized, sustainable processes with clear ownership and increased compliance
• Identifies trends in labeling-related regulatory enforcement and incorporates them into regulatory decisions and strategy
• Provides strategic oversight of Labeling Management for artwork development, review, and approval for US, EU, and international packaging components; ensures launch readiness
• Champions digital innovation, including e-labeling and structured content management
• Participates in and drives Global Labeling Policy; collaborates to influence regulatory policy and digital labeling
• Keeps abreast of regulatory changes and authority requirements to enhance team effectiveness
• Accountable for effective and efficient execution of the E2E Labeling process and full regulatory compliance
• Ensures audit readiness and compliance with global regulatory standards and internal policies

Qualifications

• PhD / PharmD / MD or equivalent, with thorough understanding of scientific principles, regulatory and business issues; 15+ years of Pharma/R&D experience with broad regulatory expertise
• Demonstrates strategic vision and the ability to set direction aligned with company objectives
• Exhibits strong executive presence and influence across program teams and organizational initiatives
• Authentically builds trusted relationships and collaborates across global, diverse, and multidisciplinary teams
• Strong judgment of talent with the ability to make tough talent decisions
• Excellent communication and stakeholder engagement skills across functions and geographies
• Experience in upskilling teams, promoting digital transformation, and embedding agile practices
• Ability to assimilate and present complex scientific and regulatory information concisely
• Understands regulatory implications of product strategy related to labeling development, assessment, and management
• Strong problem-solving, decision-making, and analytical skills
• Commitment to professional and ethical business practices
• Fosters a digital-first mindset and builds digital capabilities across teams