Executive Director, Global Labeling

Overview

Bristol Myers Squibb offers challenging, meaningful, life-changing work across all departments. From optimizing a production line to breakthroughs in cell therapy, this environment supports growth and opportunity at scale and scope, with high-achieving teams. 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 Executive Director oversees labeling management, labeling compliance, process optimization, and policy development, and serves as the global process owner for end-to-end labeling operations.

The responsibilities listed are a summary and other responsibilities may be required as assigned.

• 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; identifies necessary resources to ensure Global Labeling is adequately staffed and trained to fulfill its function in providing consistent standards of support and achieving superior execution of plans.
• 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, as appropriate.
• Develops strong working relationships with key stakeholders within Global Regulatory Sciences, Drug Development, Medical, Global Product Development & Supply, and BMS enterprise.
• Acts as a credible, influential and respected 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 the End-to-End (E2E) Labeling Initiative to establish a well-documented, optimized, sustainable E2E labeling process with clear ownership and increased compliance.
• Identifies trends in labeling-related regulatory authority compliance enforcement, policies and procedures; incorporates into regulatory decisions and strategy.
• Provides strategic oversight of Labeling Management responsible for development, review and approval of artwork for US, EU and international packaging components and ensure launch readiness for BMS products.
• 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 climate with respect to labeling content and electronic labeling.
• Keeps abreast of regulatory changes, authorities and requirements to enhance the effectiveness of the team and execution of regulatory deliverables.
• Ensures effective and efficient execution of the E2E Labeling process with full compliance to internal and external regulatory requirements.
• Ensures audit readiness and compliance with global regulatory standards and internal policies.

• PhD / Pharm
  
  D / MD or equivalent, with thorough understanding of scientific principles, regulatory and business issues with 15 years of Pharma / R&D experience with broad regulatory experience
• 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 multi-functional teams to drive business objectives.
• Serves as a strong judge of talent with the ability to make tough talent decisions.
• Possesses excellent communication and stakeholder engagement skills across functions and geographies.
• Has experience in upskilling teams, promoting digital transformation, and embedding agile practices.
• Assimilates and presents complex scientific and regulatory information concisely.
• Understands regulatory implications of product strategy related to labeling development, assessment, and management.
• Demonstrates strong problem-solving, decision-making, and analytical skills.
• Commits to professional and ethical business practices.
• Fosters a digital-first mindset and builds digital capabilities across teams.

$259,530 - $314,490. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting…