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EisaiPosted 3 weeks ago

Director, Global Labeling

$188,900–$247,900 year

RemoteUnited States

Full TimeSenior LevelLarge

Job Summary

Lead global regulatory labeling strategy and execute the development of US, EU, Growth, and Rest of World market documents, including CCDS, USPI, EU SmPC, and Country Product Information. Manage labeling operations, workflows, and centralized repositories within the electronic document management system while ensuring compliance with FDA, EMA, and other international directives. Oversee a high-performing team of Labeling Strategists, providing coaching, performance management, and resource allocation. Act as the global regulatory labeling representative on international project teams to support Target Product Profile development and maintain competitive labeling standards through competitor analysis. Liaise with co-promote partners and Packaging Engineering functions to ensure timely, efficient, and compliant implementation of safety changes across all product lines.

Required Qualifications

  • Bachelors degree in life sciences
  • Minimum of 10 years of experience in Regulatory, R&D or related areas
  • Pharmaceutical experience
  • Solid working knowledge of drug development process
  • Solid working knowledge and experience of global regulatory labeling environments and requirements
  • Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and guidelines
  • Ability to work under tight timelines and thrive under pressure
  • Attention to detail and ability to articulate findings

Desired Qualifications

  • Higher degree

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