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 has oversight for global labeling strategy, management, compliance, process ownership for E2E labeling, policy, and cross-functional labeling office leadership.

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 and achieve superior execution
• 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 BMS enterprise
• Acts as a credible, influential spokesperson; externally focused and results-driven; optimizes unit deliverables for speed to patient
• 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, policies and procedures; incorporates into regulatory decisions and strategy
• Strategic oversight of Labeling Management responsible for development, review and approval of artwork for US, EU and international packaging components and launch readiness
• Champions digital innovation, including e-labeling and structured content management
• Participates in and drives Global Labeling Policy, partnering with Global Regulatory Policy; identifies opportunities to influence regulatory policy and electronic labeling
• Keeps abreast of regulatory changes and requirements to enhance team effectiveness and delivery
• Accountable for the 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 15 years of Pharma/R&D experience and 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 initiatives
• Builds trusted relationships and collaborates across global, diverse, and multi-functional teams
• Strong judgment in talent decisions and excellent communication and stakeholder engagement skills
• Experience upskilling teams, promoting digital transformation, and embedding agile practices
• Ability to assimilate and present complex scientific and regulatory information concisely
• Understanding of regulatory implications of product strategy related to labeling development 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 the team