Associate Director, Regulatory Affairs Lead

3 days ago


Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

About Our Company

We are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.

Job Summary

The Associate Director, Global Labeling Lead will oversee the development and implementation of labeling content and strategy for multiple assigned products. This role requires strong leadership skills, expertise in regulatory affairs, and excellent communication skills.

Responsibilities

  • Lead cross-functional teams to develop and implement labeling strategies
  • Interface with senior management to ensure alignment and effective communication
  • Author, submit, and negotiate labeling documents
  • Manage local exceptions and interactions with local regulatory authorities
  • Develop and implement escalation processes and stakeholder management
  • Conduct precedent searches and analyze labeling trends
  • Collaborate with labeling teams and GRA to achieve goals
  • Manage vendors and implement continuous improvement initiatives

Qualifications

  • Bachelor's degree or equivalent required; advanced scientific degree preferred
  • At least 8 years of pharmaceutical industry experience
  • Strong knowledge of US and EU product labeling requirements, regulations, and guidelines
  • Knowledge of other relevant regional regulatory nuances and requirements
  • Knowledge of scientific principles and regulatory/quality systems relevant to drug development

Compensation

$149,100 - $234,300 per year



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