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Global Labeling Lead at Takeda Pharmaceutical Company Limited - ApplyBlast

Global Labeling Lead

Takeda Pharmaceutical Company Limited

3 months ago

Cambridge, MA, United States

Hybrid

Full Time

Senior

0 applicants

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About this role

The Global Regulatory Labeling Strategy Lead drives regulatory labeling strategies for the Plasma-Derived Therapies business unit, ensuring compliance with US and EU regulations. This role involves managing the lifecycle of core data sheets and prescribing information, leading cross-functional labeling teams, and providing expert guidance on drug-device combinations. The position requires formulating innovative strategies to support product commercialization and global expansion while maintaining high-quality documentation standards.

Responsibilities

Drive regulatory labeling strategy for the Plasma-Derived Therapies business unit
Lead cross-functional labeling teams in developing and maintaining product labels
Formulate innovative strategies for new and revised prescribing information
Provide expert advice on current labeling requirements and Health Authority guidance
Manage the lifecycle of Company Core Data Sheets and regional labeling

Skills

Qualifications

Bachelor's or Master's degree7-10 years biopharmaceutical industry experience5-7 years global labeling role experienceLeadership experience managing direct reportsKnowledge of EU and US labeling requirements