Director, Labelling Strategy & Development, Therapeutic Area Lead

GlaxoSmithKline

Hybrid (2-3 days on-site per week)
5+ years regulatory affairs experience
3+ years global labelling development
Line management of labelling teams
GSK is seeking a Director of Labelling Strategy & Development to lead global labelling management for therapeutic areas, ensuring compliance and alignment with regulatory requirements. The role involves strategic oversight, cross-functional collaboration, and innovative labelling approaches to enhance patient-focused communication

Job Summary

  • The role is accountable for directing global delivery and early lifecycle labelling development for assigned therapeutic areas from Phase 2 to early lifecycle.
  • Candidates must provide strategic direction for labelling governance issues and serve on the Global Labelling Committee while ensuring compliance with external regulations.
  • This hybrid position requires regular on-site collaboration, typically 2 to 3 days per week, to foster cohesive end-to-end labelling approaches.

Matching Summary

Match Score: 85

GSK is seeking a Director of Labelling Strategy & Development to lead global labelling management for therapeutic areas, ensuring compliance and alignment with regulatory requirements. The role involves strategic oversight, cross-functional collaboration, and innovative labelling approaches to enhance patient-focused communication.

Skills & Requirements

Must-have

  • 5+ years regulatory affairs experience
  • 3+ years global labelling development
  • Line management of labelling teams
  • Bachelor's degree in life sciences
  • Knowledge of FDA/EMA regulations

Nice-to-have

  • Advanced degree in scientific discipline
  • Experience with patient-focused labeling
  • Track record mentoring colleagues
  • Collaborative and curious mindset
  • Experience with commercial objectives alignment

Key Requirements

  • Bachelor's degree in life sciences or pharmacy
  • Minimum 5 years regulatory affairs experience
  • At least 3 years leading global labelling development
  • Line and matrix leadership experience required

Work Rights

Not specified

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