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 assigned products in various stages of drug development, including potential updates to or creation of a new Target Labeling Page (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 (Global Labeling Oversight Committee ‚Äì GLOC) and ensure preparation and alignment of GLOC chairs and members.
• Author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, incorporating input from relevant functions with appropriate supervision.
• 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 risk of write-offs.
• Manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
• Coordinate global labeling sub-functions to ensure timely label creation and Health Authority submissions; participate in label negotiations with Health Authorities (leading or with GRL).
• Interpret laws and guidance documents relevant to labeling documentation and ensure Takeda labeling content conforms to regulatory requirements.
• Align local labeling with CCDS for assigned products, assessing exceptions/deferrals and supporting local affiliates in responses to health authorities.
• Escalate issues to Global Labeling management and GRL; propose risk mitigation strategies and cultivate relationships across functions for effective labeling communication.
• Conduct precedent searches and analyze competitor labeling and health authority requests to develop labeling language that aligns with product strategy and remains competitive.
• Represent Global Labeling in Global Regulatory Team (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 related to products and processes.
• Oversee labeling activities managed by external vendors and ensure timely delivery and quality.
• Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

• 8+ years in the pharmaceutical industry, including 6 years of labeling experience or a combination of 5+ years regulatory and related experience.
• Strong knowledge of US and EU product labeling requirements (USPI and EU SmPC experience required).
• Knowledge of US and/or EU regulatory requirements and guidelines; familiarity with regional regulatory nuances.
• Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to create, revise, 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; experience with Health Authority audits and inspections.

Education

• Bachelor‚Äôs degree required; BA accepted; advanced scientific degree (MSc, PhD, or PharmD) preferred.