Director, Global Product Labeling

Essential Functions:

Provide strategic leadership and resourcing oversight for Global Product Labeling activities, ensuring appropriate support for global submissions, lifecycle maintenance, and business priorities, including input into annual labeling budget planning.

• Lead and drive the endtoend Labeling Committee (LC) process, providing project management and strategic direction from the decision to update a CCDS or product information (including patient information labeling), through crossfunctional alignment and stakeholder notification, ensuring deliverables meet internal SOPs and global regulatory expectations.
• Develop and guide labeling content strategy for new and updated labels by proactively researching global labeling precedents, competitor labels, and classlabeling trends; translate insights into clear strategic recommendations and contingency positions for health authority negotiations.
• Schedule, coordinate, and lead LC meetings, drive decisionmaking, and facilitate timely, highquality internal endorsements of labeling content.
• Serve as a subject matter expert on global labeling requirements, maintaining deep knowledge of worldwide regulatory frameworks, emerging guidelines, and industry best practices; advise crossfunctional teams on strategic application to product labeling and content development.
• Oversee the controlled records and governance of global labeling, ensuring traceability of historical, current, and proposed label changes, and communicating updates to all relevant stakeholders at implementation.
• Own quality oversight for the full labeling process, including review management, revision control, workflow execution, and timely issue resolution to ensure accuracy, consistency, and regulatory compliance.

Champion continuous improvement, driving enhancements to labeling processes, systems, and tools to increase efficiency, clarity, and effectiveness across the global labeling function. labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development/maintenance of labelling and advise key stakeholders on the application of these labelling principles

Maintain controlled records for historical, current, and proposed labelling changes, and communicate labelling changes to necessary stakeholders at the time of implementation

Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution

Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process

Required Knowledge, Skills, and Abilities:

• Progressive pharmaceutical industry experience, with specialized experience in US/EU product labeling.
• Demonstrated expertise in global labeling regulations, regulatory agency expectations, and strategies for successful health authority negotiations.
• Strong strategic judgment and decisionmaking capabilities, particularly in complex or ambiguous regulatory environments.
• Exceptional written and verbal communication skills with the ability to articulate labeling strategy and rationale to diverse stakeholders.
• Proven ability to critically review labeling documents for regulatory accuracy, data alignment, and consistency across global markets.
• Effective leadership skills with the ability to influence, collaborate, and drive alignment across crossfunctional teams and senior stakeholders.
• Ability to operate independently and within matrix teams at a high level of professionalism and accountability.
• Ability to manage priorities across multiple projects and work effectively with stakeholders at all levels.
• Willingness to travel regionally and internationally (<10%).
• Flexibility to work outside standard hours to meet business needs.

Required/Preferred Education and Licenses:

• Bachelor's degree required (Scientific discipline preferred)
• Proven experience in regulatory affairs with particular focus on labelling

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