Associate Director, Global Labeling Lead

3 days ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time
About the Role:

Takeda Pharmaceutical is seeking an experienced Associate Director to lead our Global Labeling team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing labeling content and strategy for multiple assigned products.

Key Responsibilities:
  • Develop and implement labeling content and strategy for assigned products
  • Manage Labeling Cross-Functional Teams and interface with Senior Management Cross-Functional Team (GLOC)
  • Author and manage outgoing communications regarding significant labeling changes and CCDS changes
  • Employ strong project management skills to coordinate global labeling sub-functions
  • Interpret laws, regulations, and guidance documents relevant to labeling documentation
  • Manage process for alignment of local labeling with CCDS for assigned products
  • Escalate issues to Global Labeling management and propose risk mitigation strategies
  • Develop and cultivate strong relationships among functions represented at the Labeling cross-functional teams
  • Conduct precedent analysis and develop strategies for labeling language
  • Represent Global Labeling at Global Regulatory Team (GRT) and liaise with US Labeling Operations, EU Labeling Operations, and Labeling Devices Lead
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
  • Knowledge of US and/or EU regulatory requirements and guidelines
  • Knowledge of other relevant regional regulatory nuances and requirements
  • Ability to create, revise, and/or update product labeling for regulatory submissions
  • Ability to develop target labeling profile (TLP)
  • 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 Pharmaceutical:

Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics protected by law.

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