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.
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)
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.
Targeted Base Salary
$211,083 - $260,749 USD
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