Director, Global Regulatory Labeling Strategy

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformational therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

About the role

Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, 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.
• Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) in alignment with TAU/MPD Labeling Lead, ensuring preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
• Independently authors 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.
• Develops and executes a labeling implementation plan to incorporate new scientific, safety, and clinical data, as well as Health Authority responses/feedback into CCDS, USPI, and EU SmPC, ensuring up-to-date information compliant with labeling requirements while minimizing the risk of write-offs.
• Works with direct reports to develop and/or review the labeling implementation plan to ensure compliance and minimize risk.
• Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
• Employs strong project management skills to coordinate global labeling sub-functions, ensuring timely end-to-end label creation, Health Authority submission, and key role in label negotiations with Health Authorities.
• Assesses and interprets laws, regulations, and guidance documents relevant to labeling documentation, ensuring Takeda labeling content and processes conform to regulatory requirements.
• Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals.
• Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions, and alignment deferrals.
• Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL), proposing risk mitigation strategies for assigned products.
• Spearheads the establishment and cultivation of relationships among functions represented at Labeling cross-functional teams, including clinical, safety, medical affairs, and commercial.
• Conducts precedent searches, analyzes competitor labeling, health authority labeling requests, and trends to develop strategies and labeling language for inclusion in assigned product labels (TLP, CCDS, USPI, EU SmPC).
• Analyzes competitor labeling and recent product approvals to drive innovative, industry-leading product labeling.
• Represents Global Labeling at Global Regulatory Team (GRT) and liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to ensure labeling objectives and timelines are met.
• Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
• Effectively manages resources and staff, providing guidance, supervision, and support to GLLs in carrying out their labeling responsibilities.
• Supports the professional development of staff members and manages their performance.
• Demonstrates ownership to drive team goals, fostering accountability while focusing on the big-picture labeling strategy.
• Oversees labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
• Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency, and accuracy.

Requirements

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

Skills

• Strategic Thinking: Ability to develop and execute clear, practical regulatory strategies based on regulatory requirements, competitive landscape, and business objectives. Demonstrates strong understanding of core business aspects and ability to collaborate with global cross-functional teams.
• Analytical and Problem-Solving Skills: Deep understanding of analytical methodologies and problem-solving techniques to handle complex problems. Ability to comprehend, explain, and communicate complex labeling-related regulatory issues and proactively anticipate issues or opportunities.
• Technical: In-depth expertise of US and EU product labeling requirements, regulations, and guidelines. Ability to independently create, revise, and update product labeling (CCDS, USPI, EU SmPC) and develop target labeling profiles (TLP). Strong understanding of global labeling processes and implications across the organization.
• Business/Organizational Awareness: Knowledge of labeling’s role in project teams and cross-functional collaboration. Demonstrates proactive project management skills and ability to align global labeling strategies with broader business objectives.
• Leadership: Ability to lead multi-disciplinary, cross-functional teams and foster a climate of open dialogue and diverse opinions. Accurately identifies strengths and development needs in others and invests time to enhance team skills and talent.
• Core Competencies:
  • Demonstrates Takeda values: Integrity, fairness, honesty, and perseverance.
  • Ethical decision-making that considers the impact of decisions and aligns with Takeda values.
  • Strong timeline management, proactiveness, adaptability, and flexibility.
  • Attention to detail and ability to work with diverse global teams.