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Associate Director, Global Labeling
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Full-time
- 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.
- 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.
- Advanced scientific degree (MSc, PhD, or PharmD) preferred;
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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