Associate Director, Global Labeling Lead (REMOTE)

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Job Description

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innofvation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine

The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is:

• Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device.
• Ensuring that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
• Formulating regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
• Providing expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.

ACCOUNTABILITIES

• Drives labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.
• Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.
• Provides guidance on combination product/drug-device labeling.
• Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities
• Prepares backup strategies in support of labeling negotiations.
• Takes initiative in leading global labeling team and cross-functional projects.
• Leads CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
• Project manages new or updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manages and facilitates review of CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products.
• Prepares final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manages the preparation of submission-ready labeling components, consults with affiliates on Health Authority communications regarding labeling.
• Ensures internal and external stakeholder awareness of proposed and newly approved labeling changes, as required.
• Ensures compliant version control of product labeling and other related documentation within the Takeda document management systems.
• Ensures QC of CCDSs and other labeling documents.
• Updates labeling decision records to ensure labeling history is appropriately tracked and archived.
• Ensures Takeda employee awareness of, and adherence to, Takeda Labeling processes via regulatory training.

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