Director, Global Regulatory Labeling Strategy

Role Summary

Director, Global Regulatory Labeling Strategy at Takeda. Responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

Responsibilities

• Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content.

• Coordinate labeling approval processes with the Global Labeling Oversight Committee (GLOC), ensuring preparation and alignment of GLOC Chair(s) and members.

• Independently author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.

• Direct reports develop/review labeling implementation plans to provide up-to-date, compliant information to patients and healthcare providers while minimizing write-offs.

• Independently author/manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products.

• Coordinate global labeling sub-functions to ensure timely end-to-end label creation, Health Authority submissions, and lead or contribute to label negotiations with Health Authorities.

• Assess and interpret laws, regulations, and guidance documents relevant to labeling documentation and ensure Takeda labeling content and processes conform to regulatory requirements.

• Manage alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals; support Local Affiliates with health authority responses and labeling alignment.

• Escalate issues to Global Labeling management and the Global Regulatory Lead, proposing risk mitigation strategies; cultivate relationships across functions to ensure effective labeling strategy and content communication.

• Conduct precedent searches and analyze competitor labeling and health authority labeling requests to develop strategies and labeling language for product labels, ensuring consistency with product strategy.

• Represent Global Labeling at Global Regulatory Team (GRT) and liaise with labeling operations and compliance to meet objectives and timelines; participate in inspections.

• Manage resources and provide guidance to labeling team members; support professional development and maintain accountability for team goals.

• Oversight of labeling activities managed by external vendors; ensure coordination, timely delivery, and quality adherence.

• Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

• BSc degree preferred; advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 10+ years of pharmaceutical industry experience, including 8 years of labeling experience or 6+ years regulatory/related experience.

Skills

• Strategic thinking and ability to develop regulatory strategies aligned with business objectives.
• Strong communication and collaboration across global cross-functional teams; ability to present to diverse stakeholders.
• Analytical and problem-solving skills to handle complex labeling regulatory issues and risk mitigation.
• Technical expertise in US/EU labeling requirements; ability to create/update labeling for submissions; knowledge of audit processes.
• Leadership and people management, with ability to lead multi-disciplinary teams and foster an inclusive environment.

Education

• BSc required; MSc/PhD/PharmD preferred.

Additional Requirements

• Remote in Massachusetts; work requires coordination across global teams and Health Authority interactions.