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 drug development stages, including potential updates 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 approvals with the Global Labeling Oversight Committee (GLOC) and prepare/align GLOC chairs and members.
• Author new or revised TLP, CCDS, USPI and/or EU SmPC with input from relevant functions and appropriate supervision.
• Develop and execute labeling implementation plans to incorporate new data and Health Authority feedback into CCDS, USPI, and EU SmPC, ensuring compliance and minimizing write-offs.
• Manage outgoing communications regarding significant labeling changes and CCDS changes with supervision.
• Coordinate global labeling sub-functions to ensure timely label creation, Health Authority submissions, and lead or co-lead label negotiations with authorities.
• Interpret laws and guidance documents to ensure labeling content conforms to regulatory requirements.
• Manage alignment of local labeling with CCDS, assess exceptions/deferrals, and support local affiliates in responses to health authorities.
• Escalate issues to Global Labeling management and GRL; develop risk mitigation strategies; foster cross-functional relationships to ensure effective labeling communication.
• Conduct precedent searches and monitor labeling trends; develop labeling language for products to ensure consistency with strategy and claims.
• Represent Global Labeling in GRT and liaise with labeling operations and compliance to meet objectives and timelines.
• Support health authority inspections by providing labeling information requests.
• Oversee labeling activities managed by external vendors for assigned products.
• 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 and/or EU regulatory requirements and guidelines, and other regional nuances.
• Ability to create/update CCDS, USPI, and EU SmPC for regulatory submissions with minimal supervision.
• Ability to develop target labeling profiles (TLP) with minimal supervision.
• Understanding of global labeling concepts and their implications across the organization.
• Knowledge of Health Authority audit processes and ability to participate in audits/inspections.

Education

• BSc degree required or preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.