Director, Regulatory Labeling
Akebia Therapeutics
June 26, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Job Summary
- Director, Regulatory Affairs – Labeling responsible for shaping and executing global labeling strategy across the portfolio.
- Enterprise expert on labeling; partners cross-functionally to ensure labeling is scientifically robust, commercially aligned, and compliant with evolving global regulatory requirements.
Essential Duties & Responsibilities
- Strategic Leadership: Define and lead global labeling strategy (USPI, CCDS, ex-US) across development and marketed products; advise senior leadership on labeling risks/opportunities/positioning; drive labeling as part of overall regulatory/product strategy.
- Cross-Functional Influence: Lead labeling teams with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC; facilitate alignment on labeling decisions balancing compliance and business objectives; represent labeling strategy in governance forums and regulatory interactions.
- Labeling Development & Lifecycle Management: Oversee development/negotiation/maintenance of USPI, CCDS, and local labeling; lead labeling strategy for INDs, NDAs/sNDAs, MAAs, and major label updates; ensure global document consistency/alignment.
- Regulatory Intelligence & Policy: Monitor/interpret FDA, EMA, and global labeling regulations/guidance/enforcement; translate intelligence into internal guidance; benchmark competitor labeling for differentiation.
- Operational Excellence & Oversight: Ensure execution of labeling processes; oversee SPL submissions/compliance for U.S.; drive continuous improvement; manage downstream implications of approved labeling changes; manage labeling vendors and ensure version control/tracking/inspection readiness.
Basic/Preferred Qualifications
- Bachelor’s degree in a scientific or related discipline.
- ~10+ years pharmaceutical/biotech experience with 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, ICH regions).
Compensation & Benefits
- Targeted Base: $209,345–$258,603. Additional rewards may include corporate/incentive bonus and equity; health care, vision, dental, retirement, PTO.
Application Instructions
- Not provided in the text.
- Director, Regulatory Affairs – Labeling responsible for shaping and executing global labeling strategy across the portfolio.
- Enterprise expert on labeling; partners cross-functionally to ensure labeling is scientifically robust, commercially aligned, and compliant with evolving global regulatory requirements.
Essential Duties & Responsibilities
- Strategic Leadership: Define and lead global labeling strategy (USPI, CCDS, ex-US) across development and marketed products; advise senior leadership on labeling risks/opportunities/positioning; drive labeling as part of overall regulatory/product strategy.
- Cross-Functional Influence: Lead labeling teams with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC; facilitate alignment on labeling decisions balancing compliance and business objectives; represent labeling strategy in governance forums and regulatory interactions.
- Labeling Development & Lifecycle Management: Oversee development/negotiation/maintenance of USPI, CCDS, and local labeling; lead labeling strategy for INDs, NDAs/sNDAs, MAAs, and major label updates; ensure global document consistency/alignment.
- Regulatory Intelligence & Policy: Monitor/interpret FDA, EMA, and global labeling regulations/guidance/enforcement; translate intelligence into internal guidance; benchmark competitor labeling for differentiation.
- Operational Excellence & Oversight: Ensure execution of labeling processes; oversee SPL submissions/compliance for U.S.; drive continuous improvement; manage downstream implications of approved labeling changes; manage labeling vendors and ensure version control/tracking/inspection readiness.
Basic/Preferred Qualifications
- Bachelor’s degree in a scientific or related discipline.
- ~10+ years pharmaceutical/biotech experience with 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, ICH regions).
Compensation & Benefits
- Targeted Base: $209,345–$258,603. Additional rewards may include corporate/incentive bonus and equity; health care, vision, dental, retirement, PTO.
Application Instructions
- Not provided in the text.