Director, Regulatory LabelingCambridge, Massachusetts, United States

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.

The successful candidate will be a strategic thinker who can translate complex regulatory frameworks into clear business objectives, an effective influencer who is able to drive alignment across senior cross-functional stakeholders, be decisive and solutions-oriented, with the ability to navigate ambiguity and regulatory risk, have deep expertise in FDA labeling regulations and evolving global expectations, and be a collaborative leader who builds trust, fosters accountability, and elevates team performance

This role sits at the intersection of regulatory strategy, clinical development, and commercialization-driving labeling as a critical asset to maximize product value throughout the lifecycle, from early development through post-marketing optimization.

This role reports to the VP, Regulatory Affairs.

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)

Targeted Base Salary

$211,083 - $260,749 USD