Takeda · 17 hours ago
Senior Manager, Global Regulatory Labeling Strategy - Remote
United States
Full-time
Remote
Senior Level
$137K/yr - $215K/yr
6+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Senior Manager, Global Regulatory Labeling Strategy will be responsible for the development and implementation of labeling content and strategy of assigned products in various stages of drug development, ensuring cross-functional collaboration and compliance with regulatory requirements.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervision and guidance
Assists in the development of labeling strategies and content and to ensuring cross-functional alignment for other medium and/or high complexity products
Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels, with appropriate supervision, guidance and alignment with TAU/MPD Labeling Lead
Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions
Authors 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 appropriate 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
Authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance
Employs project management skills to interface with global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities
Ensures labeling content conform to regulatory requirements
Manages the 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
Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure highly effective communication of 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 assigned product labels (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
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
Participates 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
Assist in managing high complexity products by working with GLLs and labeling management on assigned labeling tasks such as review and edit labeling documents, assist in leading LWG meetings, coordinate labeling local update / exception process etc
Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards
Qualification
Required
BSc degree, preferred; BA accepted
6+ years of pharmaceutical industry experience. This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and/or related experience
Knowledge of US and EU product labeling regulatory requirements and guidelines
Familiarity with US and/or EU regulatory requirements and guidelines
Familiarity with other relevant regional regulatory nuances and requirements
Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development
Ability to co-author, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance
Ability to identify factors and requirements necessary for regulatory recommendations
Ability to develop regulatory strategies based on regulatory requirements and competitive landscape
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
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
2026-01-09
2026-01-08
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