Takeda · 4 days ago
Director, Global Regulatory Labeling Strategy
United States
Full-time
Hybrid
Director/Executive
$174K/yr - $274K/yr
10+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Director, Global Regulatory Labeling Strategy will be responsible for the development and implementation of labeling content and strategy for multiple products, ensuring compliance with regulatory requirements and fostering cross-functional collaboration.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content
In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels
Ensures 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
In a highly efficient manner, 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 enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs
Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write-offs is minimized
Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products
Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL)
Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements
Manages 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, etc
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation
Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content
Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals
Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals
Represents Global Labeling at Global Regulatory Team (GRT)
Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met
Embraces pivotal role in departmental and cross-functional task-forces and initiatives
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 to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities
Supports the professional development of staff members and effectively manages their performance
Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy
Oversight and accountability for 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
Qualification
Required
10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience
Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives
Demonstrates a strong understanding of the core business aspect
Ability to effectively collaborate with global cross-functional teams and to deliver engaging and valuable presentations to diverse stakeholders
Ability to build a collaborative network of relationships across global cross-functional teams
Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format
Ability to advocate for regulatory decisions across global cross-functional teams
Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding
Demonstrates deep understanding of analytical methodologies and problem-solving techniques to handle complex problems
Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues
Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities
Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately escalate to leadership
In-depth expertise of US and EU product labeling requirements, regulations, and guidelines
Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape
Understanding of other relevant regional regulatory nuances and requirements
Understanding of scientific principles and regulatory/quality systems relevant to drug development
Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions
Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives
Ability to independently develop target labeling profile (TLP)
Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling
Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections
In depth knowledge of labeling role in project teams, and importance of cross-functional collaboration
Knowledge of organizational structure, including its functions and interdependencies
Demonstrates proactive project management skills and ability to independently deliver accurate and complete work while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives
Demonstrates a strong strategic mindset and ability to independently align global labeling strategies with broader business objectives
Ability to plan and prioritize global labeling activities and tasks for the assigned product(s) and to assign tasks appropriately
Acts proactively and effectively as member of multi-disciplinary teams
Ability to independently and effectively lead multi-disciplinary, cross-functional teams
Displays leadership skills that foster a climate that encourages open dialogue, feedback and diverse opinion and an environment where ideas are exchanged, alignment is created and teams experiment and learn from success and failures
Accurately identifies strengths and development needs in others and invests time to help enhance the skills, quality, depth and talent of their team
Ability to distil complex issues and ideas down to simple comprehensible terms
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Demonstrates Takeda values Integrity, fairness, honesty, and perseverance
Ethical decision making considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with Takeda values
Timeline management ability to effectively manage self and team's time, prioritize tasks, meet deadlines and maximize team productivity
Proactiveness, adaptability and flexibility ability to adapt to fast changing circumstances, learn new skills and work with diverse global team by being open to feedback and being able to adjust to different working styles, organizational and process changes
Attention to details demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s). Ability to review labeling deliverables ensuring accuracy and compliance
Negotiation skills demonstrates exceptional negotiation skills in complex situations, such as executive-level decision-making, ensuring optimal outcomes for the organization
Preferred
BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred
Benefits
Short-term and/ or long-term incentives
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-07
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