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TakedaPharmaceutical Nordics AB · 2 hours ago

Associate Director, Global Labeling Lead

Boston, MA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$154K/yr - $241K/yr

8+ years exp

TakedaPharmaceutical Nordics AB is a forward-looking, world-class R&D organization focused on delivering 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 in various stages of drug development, ensuring compliance with regulatory requirements and driving cross-functional collaboration.

Pharmaceuticals

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

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

Labeling strategy developmentUSEU labeling requirementsLabeling document authoringRegulatory compliance knowledgeProject management skillsStakeholder managementContinuous improvement mindsetCross-functional collaboration

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