JOB DESCRIPTION:

We are seeking an experienced Global Regulatory Labeling professional to lead strategic and operational labeling activities across the product lifecycle. The Senior Manager, Core Labeling will be responsible for the development, maintenance, and implementation of global core labeling documents including CCDS, USPI, EU SmPC, and associated patient information while ensuring compliance with global regulatory requirements.

This role partners cross-functionally with Regulatory Affairs, Clinical, Safety, Medical Affairs, and Commercial teams to support labeling strategy, regulatory submissions, promotional review, and lifecycle management activities for global pharmaceutical products.

Key Responsibilities

• Lead development, review, approval, and maintenance of global core labeling documents including:
  • CCDS (Company Core Data Sheet)
  • USPI
  • EU SmPC
  • Core Patient Information
• Drive global labeling strategy aligned with overall regulatory and business objectives.
• Support Target Product Labeling (TPL) development and competitive labeling assessments.
• Provide strategic labeling guidance for major submissions including:
  • NDA
  • BLA
  • MAA
  • FDA and EMA interactions
• Evaluate clinical and non-clinical data to support scientifically accurate and compliant labeling updates.
• Partner with cross-functional stakeholders including:
  • Regulatory Affairs
  • Medical Affairs
  • Pharmacovigilance/Safety
  • Clinical Development
  • Commercial teams
• Lead or participate in Product Labeling Teams (PLTs) and support Global Labeling Committee (GLC) activities.
• Review and approve promotional and non-promotional materials for compliance with core labeling and regulatory requirements.
• Monitor evolving global labeling regulations, competitor labeling, and industry trends.
• Support responses to Health Authority labeling queries and regulatory requests.
• Provide mentoring, leadership, and strategic guidance within a matrix organization.

Required Qualifications

Education

• Bachelor s degree in:
  • Pharmacy
  • Life Sciences
  • Medicine
  • Pharmacology
  • Related scientific discipline

Preferred:

• PharmD, MSc, or PhD

Experience

• 7 10+ years of Regulatory Affairs experience
• Strong global labeling experience within pharmaceutical or biotech industry
• Proven experience managing:
  • CCDS
  • USPI
  • EU SmPC
  • Global labeling lifecycle activities
• Experience supporting FDA and EMA submissions preferred.
• Prior experience in:
  • TPL development
  • Competitive labeling analysis
  • Regulatory strategy support
• Demonstrated ability to lead in a matrixed global environment.

Required Skills

• Global Regulatory Labeling expertise
• Strong knowledge of FDA and EMA labeling requirements
• Regulatory submission support
• Strategic thinking and problem solving
• Cross-functional leadership
• Promotional material review
• Scientific and clinical data interpretation
• Excellent communication and stakeholder management skills