Associate Director, Global Labeling Lead

Role Summary

Associate Director, Global Labeling Lead at Takeda. Responsible for the development and implementation of labeling content and strategy for multiple products across various stages of drug development, including potential updates to or creation of TLP, CCDS, USPI, and EU SmPC, with limited supervision.

Responsibilities

• Independently lead labeling cross-functional teams to drive collaboration and alignment of labeling strategy and content.
• Coordinate labeling approval processes with Senior Management Cross-Functional Team (GLOC) to align labeling strategy and content at all levels.
• Prepare and align GLOC Chair(s) and members through respective functions.
• Author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from relevant functions with appropriate annotations and documentation.
• Develop and execute labeling implementation plans to incorporate new data and Health Authority feedback into CCDS, USPI, and EU SmPC while ensuring compliance and minimizing write-offs.
• Author/manage outgoing communications regarding significant labeling changes and CCDS updates with supervision.
• Coordinate global labeling sub-functions to ensure timely label creation and Health Authority submissions; lead or co-lead label negotiations with Health Authorities.
• Interpret laws and guidance and ensure labeling content complies with regulatory requirements.
• Manage alignment of local labeling with CCDS for assigned products, assess exceptions/deferrals, and support local affiliates in responses to health authorities.
• Escalate issues to Global Labeling management and GRL; develop risk mitigation strategies; build strong cross-functional relationships.
• Conduct precedent searches and analyze competitor labeling and health authority requests; develop labeling language to ensure consistency with product strategy.
• Represent Global Labeling in GRT and liaise with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet objectives and timelines.
• Support Health Authority inspections by providing labeling information requests.
• Oversee labeling activities managed by external vendors and ensure timely, quality-delivered work.
• Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

• 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or 5+ years regulatory/related experience.
• Strong knowledge of US and EU labeling requirements (USPI and EU SmPC experience required).
• Knowledge of US/EU regulatory requirements and guidelines; familiarity with regional regulatory nuances.
• Ability to create and update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with minimal supervision.
• Ability to develop target labeling profile (TLP) with minimal supervision.
• Understanding of global labeling concepts and their organizational implications; knowledge of Health Authority audit processes.
• BSc degree (preferred; BA accepted); advanced scientific degree (MSc/PhD/PharmD) preferred.