Associate Director, Global Labeling Lead

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Company Ltd Full time
About the Role

We are seeking an experienced Associate Director, Global Labeling Lead to join our team at Takeda Pharmaceutical Company Ltd. As a key member of our Global Labeling team, you will be responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development.

Key Responsibilities
  • Develop and implement labeling content and strategy for assigned products
  • Manage labeling cross-functional teams and drive cross-functional collaboration and alignment of labeling strategy and content
  • Interface with senior management cross-functional team (GLOC) and coordinate the process to obtain labeling approval
  • Ensure preparation and alignment of GLOC chair(s) and GLOC members through respective functions
  • Author new/revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas
  • Develop and execute 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
  • Independently author/manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products
  • Employ 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
  • Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assure that Takeda labeling content and processes conform to regulatory requirements
  • Manage local exceptions and LOC interactions, including assessment of exceptions and deferrals
  • Provide support to local affiliates for responses to health authorities' requests, review of local labeling exceptions, and alignment deferrals
  • Escalate issues to Global Labeling management and the Global Regulatory Lead (GRL) and propose risk mitigation strategies for assigned products
  • Strategically develop and cultivate strong relationships among functions represented at the Labeling cross-functional teams, including clinical, safety, medical affairs, and commercial
  • Conduct precedent searches, analyze relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance, and trends, and develop strategies and labeling language for assigned product labels
  • Represent Global Labeling at Global Regulatory Team (GRT) and liaise with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to ensure labeling objectives and timelines are met
  • Support 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 vendors for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards
  • Actively contribute to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency, and accuracy
Requirements
  • BSc degree, preferred; BA accepted
  • Advanced scientific degree (MSc, PhD, or PharmD) preferred
  • 8+ years of pharmaceutical industry experience, 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
About Takeda

Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as 'remote' in accordance with Takeda's Hybrid and Remote Work policy.

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