Labeling Strategist
Core
Lead end-to-end labeling activities across the pharmaceutical product life cycle, developing core and regional labeling materials to ensure safe and effective product use.
Role type
Senior regulatory affairs strategist (pharmaceutical labeling)
Builds
Core Data Sheets, patient information leaflets, prescribing information, and medication guides for global regulatory teams
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Global labeling regulations expertise, pharmaceutical regulatory affairs, therapeutic area biology/pharmacology, complex project management, strategic planning, cross-functional leadership, technical writing, regulatory information management systems
Preferred skills
Life sciences or medicine degree, Veeva or Documentum document management systems, Microsoft Office proficiency
Responsibilities
Lead Labeling Working Groups and present strategies to executive governance bodies; Develop and maintain core labeling documents; Oversee regional and U.S. labeling deliverables; Represent labeling on global regulatory teams; Provide strategic input into Target Product Labeling; Manage complex labeling activities throughout product life cycles; Advise stakeholders on labeling regulations and trends; Review and approve deviations from core labeling; Support responses to Health Authority questions; Supervise direct reports; Manage multiple regulatory timelines
Seniority
Senior, hands-on IC with mentorship responsibilities
