Director, Regulatory Labeling

Akebia Therapeutics•Cambridge, MA

22h•Hybrid

About The Position

This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. 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. The successful candidate will be a strategic thinker who can translate complex regulatory frameworks into clear business impact, a strong 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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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
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
Manage external vendors supporting labeling operations and systems
Ensure robust version control, tracking, and inspection readiness across labeling documentation