Overview Director, Labeling Council and Regional Labeling — Takeda. The role focuses on leadership for regional labeling and the Global Labeling Council, establishing a new capability to support Local Operating Company Regulatory Affairs professionals (LOCs) with on-time submissions, and acting as the point of contact for labeling dependencies, lead/dependent markets, hybrid labels, labeling processes, tools, and systems. It includes oversight of expectations for the team and stakeholders and leadership of the Global Labeling Council. How you will contribute Partner with the Head of GRA Labeling Operations to facilitate Labeling Council. Lead Labeling Council Meetings: facilitate discussions, document key decisions, and ensure active stakeholder participation to align on labeling initiatives, strategies and regulatory requirements. Track and follow up on action items from Labeling Council Meetings; monitor progress, provide updates, and address challenges to ensure timely execution of decisions. Drive activities to support Local Operations Company (LOC) Regulatory Leads for seamless execution of labeling processes; act as primary contact for LOC questions related to labeling process changes and conduct awareness sessions with LOCs about impacts on workflows. Partner with stakeholders including Global Labeling, EUCAN Regulatory Liaison and GEM Area Heads to enable excellent execution of labeling processes globally. Report regional labeling activities to stakeholders and leadership. Support standardization of Global Labeling processes and use of the RIM system and labeling tracking system at LOC level. Build and nurture awareness of the regional labeling role as the conduit between Global Labeling Leads (strategy) and LOCs. Establish an environment that supports LOCs in labeling activities, leading forums and workshops as necessary. Provide strong SME knowledge of labeling processes and regulations related to local labeling, including content exceptions and submission timeline extensions. Partner with Labeling Conformance to support on-time submissions of local labels related to global changes, including activities in labeling tracking systems. Develop and monitor metrics for regional labeling to identify insights and propose strategic actions for continuous improvement and compliance. Demonstrate Takeda leadership behaviors. Minimum Requirements / Qualifications Bachelor’s degree (or equivalent) required; master’s preferred. 7+ years in the pharmaceutical industry, with 4+ years in Regulatory Affairs, labeling, or quality assurance/compliance. Labeling SME with extensive knowledge of labeling processes (global and local) and ability to train/support LOCs and regional labeling team. Industry knowledge of regulatory affairs processes, global health authorities, regulations, product approvals, labeling, and lifecycle processes for major markets. Project management and Six Sigma experience preferred. Leadership: ability to work across functions, regions, and cultures; proven track record as an effective team leader. About Takeda Takeda is transforming patient care through novel therapies and patient support programs. We value inclusion, collaboration, and excellence, and strive to deliver Better Health and a Brighter Future. This position is classified as remote under Takeda’s Hybrid and Remote Work policy. Compensation & Benefits Summary U.S. Base Salary Range: $174,500.00 - $274,230.00. Massachusetts - Virtual location. The actual base salary will depend on qualifications, experience, and location. U.S. based employees may be eligible for incentives and benefits (medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits). Salaries are subject to state/local wage requirements. EEO Statement Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants regardless of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, veteran status, or any other protected characteristic. Locations: Massachusetts - Virtual; Worker Type: Employee; Worker Sub-Type: Regular; Time Type: Full time; Job Exempt: Yes.

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