Director, Regulatory , MA

Director, Regulatory Labeling

Regulatory Affairs

Cambridge, MA • Full-Time/Regular

This position is currently based in our Cambridge, MA office. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Summary:

The Director, Regulatory Affairs – Labeling is a highly visible leadership role responsible for shaping and executing global labeling strategy across Akebia's 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.

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
• Lead 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

Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.