Takeda · 4 hours ago
Associate Director, Global Labeling Lead
United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
8+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Associate Director, Global Labeling Lead will be responsible for the development and implementation of labeling content and strategy for multiple assigned products, ensuring compliance with regulatory requirements and managing cross-functional teams.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Independently leads Labeling cross-functional teams driving cross-functional collaboration and 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) driving cross-functional collaboration and 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
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 with appropriate supervision and guidance
With adequate supervision and guidance, 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
Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance
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)
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 with appropriate supervision and guidance
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
Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content
Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for 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
Working within Labeling Team and GRA
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
Represents global labeling 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
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
BSc degree, preferred; BA accepted
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience
Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required)
Knowledge of US and/or EU regulatory requirements and guidelines
Knowledge of other relevant regional regulatory nuances and requirements
Knowledge of scientific principles and regulatory/quality systems relevant to drug development
Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance
Ability to develop target labeling profile (TLP) with minimal supervision and guidance
Understanding of the broad concepts within global labeling and implications across the organization and globally
Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections
Preferred
Advanced scientific degree (MSc, PhD, or PharmD) preferred
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in 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, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue 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
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Trends of Total Sponsorships
2025 (34)
2024 (40)
2023 (39)
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
BioWorld Financial Watch
2025-12-21
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