Executive Director, Global Labeling

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The Executive Director, Global Labeling is a senior leadership position 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.

Key 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, priority and plans: Identifies necessary resources in order to ensure that Global Labeling is adequately staffed and trained to fulfill its function in providing consistent standards of support and in 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 the key stakeholders within Global Regulatory Sciences, within Drug Development, Medical, Global Product Development & Supply and BMS enterprise.

• Acts as a credible, influential and respected spokesperson and Is 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.

• Oversee continuous improvement of E2E Labeling Initiative to establish well-documented optimized sustainable E2E labeling process with clear ownership, simplified process steps and increased compliance.

• Identifies trends in labeling-related regulatory authority compliance 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 ensure launch readiness for BMS products.

• Champions digital innovation, including e-labeling and structured content management.

• Participates 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, changes in authorities and requirements to enhance the effectiveness of the team and execution of regulatory deliverables

• Accountable for the effective and efficient execution of the E2E Labeling process as well as ensure full compliance with all internal and external regulatory requirements

• Ensures audit readiness and compliance with global regulatory standards and internal policies.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Requirements:

• 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