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 for multiple products in various stages of drug development, including high-complexity products, and updates to or creation of TLP, CCDS, USPI and EU SmPC.

Responsibilities

• Leads labeling cross-functional teams to foster collaboration and drive alignment of labeling strategy and content.
• Coordinates with Senior Management Cross-Functional Team (GLOC) to obtain labeling approval and align labeling strategy at all levels; ensures preparation and alignment of GLOC Chair(s) and members.
• Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products with input from relevant functions; develops labeling implementation plans to incorporate new data and authority feedback while ensuring compliance and minimizing write-offs.
• Manages labeling implementation plans with direct reports to provide up-to-date information to patients and Health Care Providers; leads or co-leads label negotiations with Health Authorities.
• Authors/manages outgoing communications regarding significant labeling changes and CCDS changes; coordinates global labeling sub-functions to ensure timely label creation and submissions.
• Assesses and interprets laws, regulations, and guidance to ensure Takeda labeling content and processes conform to regulatory requirements.
• Manages local labeling exceptions and deferrals, providing support to Local Affiliates for responses to health authorities and alignment deferrals.
• Escalates issues to Global Labeling management and GRL; builds strong relationships across labeling cross-functional teams for effective communication of strategy and content.
• Conducts precedent searches and analyzes competitor labeling and health authority requests to develop strategies and labeling language that align with product strategy and claims.
• Represent Global Labeling at GRT; liaises with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet objectives and timelines; supports Health Authority inspections related to labeling processes.
• Oversees resource management and provides guidance and development for labeling staff; drives delivery of team goals and accountability.
• Oversees external vendor activities for labeling and contributes to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

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

Skills

• Strategic thinking with ability to develop and execute regulatory strategies aligned with business objectives; strong cross-functional collaboration and communication.
• Analytical and problem-solving skills to handle complex regulatory labeling issues and risk mitigation.
• Technical expertise in US and EU product labeling requirements, with ability to create/update CCDS, USPI, and EU SmPC; understanding of global labeling processes and audits.
• Business/organizational awareness including proactive project management and alignment of labeling strategies with broader objectives.
• Leadership and people-management skills to lead cross-functional teams and mentor staff; strong collaboration and negotiation abilities.

Education

• As listed in Qualifications