Global Labeling Strategy Director

Planet Pharma; Cambridge (MA); On-site; USD 180,000 - 300,000; Full time

Job summary

Planet Pharma is seeking a senior regulatory leader to define and execute global labeling strategy across the product lifecycle. You will translate clinical evidence into scientifically substantiated labeling proposals and negotiate with global regulators, including the FDA.

You will lead and develop internal teams, manage consultants, and drive the Target Product Label process while ensuring compliant labeling across markets and lifecycle milestones.

Qualifications

• 15+ years in biopharma with substantial regulatory leadership and labeling experience.
• Proven track record in FDA labeling negotiations and global strategy.
• Strong leadership, communication and cross-functional influence.

Responsibilities

• Define global labeling vision, priorities, and strategy for development and marketed products.
• Lead FDA labeling negotiations in partnership with US Regulatory Lead.
• Ensure labeling aligns with global regulatory strategy, clinical development, and lifecycle planning.
• Provide senior leadership with recommendations on labeling opportunities and regulatory risks.
• Build and mentor a high-performing global labeling organization and manage external resources.
• Develop CCDS, USPI, and EU product information in collaboration with regional teams.
• Establish substantiated labeling positions for new indications and lifecycle changes.
• Evolve Target Product Label processes and labeling governance across programs.
• Oversee regional labeling, ensuring core labeling alignment with justified local differences.

Skills

Global labeling strategy

FDA negotiations

Regulatory leadership

Cross-functional collaboration

Strategic thinking

People development

Education

Advanced life sciences degree

Job description

Planet Pharma is seeking a senior regulatory leader to define and execute global labeling strategy across the product lifecycle. You will translate clinical evidence into scientifically substantiated labeling proposals and negotiate with global regulators, including the FDA.

You will lead and develop internal teams, manage consultants, and drive the Target Product Label process while ensuring compliant labeling across markets and lifecycle milestones.