Associate Director, Global Labeling

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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Global Labeling Lead where you will be responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.

You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products.

• Lead cross functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team)

• In coordination with Global Labeling Oversight Committee (GLOC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLOC

• Evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead

• Recommend strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.

• Provide information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert

• Liaise with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met

• Analyze relevant competitor labeling to ensure Takeda products have competitive labeling possible; maintain awareness of recent in-class approvals.

• Remain current with global standards, initiative by regulatory authorities related to the CCDS and labeling, and assure that Takeda processes conform to regulatory requirements. Propose actions as needed.

• Prepare/lead training and information sessions with GRA and other functional areas to increase understanding and compliance with internal and external labeling expectations …