Associate Director, Global Regulatory Labeling Strategy

About the role

Own labeling strategy and content for several products at different development stages, from target profiles to core data sheets and regional product information. Ensure labeling is accurate, competitive and compliant worldwide.

What you will do

• Lead cross functional labeling teams and build agreement on global strategy and content
• Coordinate the labeling approval process with the oversight committee and its chairs
• Draft and maintain target profiles, core data sheets and US and EU product information
• Run implementation plans that fold in new clinical, safety and authority feedback
• Support negotiations with health authorities alongside the global regulatory lead
• Align local labeling with the core data sheet and assess exceptions and deferrals

What they look for

• Experience developing regulatory labeling strategy for multiple products across development stages
• Ability to interpret laws, regulations and guidance and apply them to labeling content
• Skill at building partnerships across clinical, safety, medical, commercial and regulatory groups
• Strength in analysing competitor labeling, authority requests and emerging trends