Director, Regulatory Labeling

Job Summary

The Director, Regulatory Affairs – Labeling is a highly visible leadership role responsible for shaping & executing global labeling strategy across Akebia’s entire portfolio. This individual will serve as the enterprise expert on labeling, partnering cross-functionally to ensure that product labeling is scientifically robust, commercially aligned, and compliant with evolving global regulatory requirements.

Essential Duties and Responsibilities

• Strategic Leadership
  • Define and lead global labeling strategy (USPI, CCDS, and ex-US labeling) across development and marketed products
  • Serve as the primary regulatory authority on labeling, advising senior leadership on risks, opportunities, and strategic positioning
  • Drive labeling as a core component of overall regulatory and product strategy, including differentiation and lifecycle optimization
• Cross-Functional Influence
  • Lead cross-functional labeling teams, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC
  • Facilitate alignment on complex labeling decisions, balancing regulatory compliance with business objectives
  • Represent labeling strategy in governance forums and regulatory interactions
• Labeling Development & Lifecycle Management
  • Oversee development, negotiation, and maintenance of USPI, CCDS, and local labeling
  • Spearhead labeling strategy for key milestones including INDs, NDAs/sNDAs, MAAs, and major label updates
  • Ensure consistency and alignment across global labeling documents
• Regulatory Intelligence & Policy Leadership
  • Proactively monitor and interpret evolving FDA, EMA, and global labeling regulations, guidances, and enforcement trends
  • Translate regulatory intelligence into actionable strategies and internal guidance
  • Benchmark competitor labeling and identify opportunities for differentiation
• Operational Excellence
  • Ensure efficient execution of labeling processes, including document development, review, approval, and implementation
  • Oversee Structured Product Labeling (SPL) submissions and compliance for U.S. requirements
  • Drive continuous improvement of labeling processes, systems, and governance
  • Ensure cross-functional teams understand downstream implications of changes to approved labeling
• Vendor & System Oversight
  • Manage external vendors supporting labeling operations and systems
  • Ensure robust version control, tracking, and inspection readiness across labeling documentation

Basic Qualifications

• Bachelor’s degree in a scientific or related discipline
• ~10+ years of pharmaceutical/biotech experience, including significant regulatory labeling experience for prescription products
• Demonstrated experience leading labeling strategy across development and/or marketed products

Preferred

• Advanced degree (MS, PharmD, PhD, JD)
• Experience supporting product launches and/or major label expansions
• Global labeling experience (FDA, EMA, and ICH regions)

Compensation

Targeted Base: $209,345- $258,603