Sr. Director, Regulatory Affairs
Akebia Therapeutics
June 27, 2026
Remote friendly (New York, United States)
United States
Corporate Functions
Job Summary
Senior Director, Regulatory Affairs to lead global regulatory strategy for vadadustat and support broader pipeline programs.
Responsibilities
- Design and lead implementation of global regulatory strategies across development programs.
- Provide strategic regulatory guidance to cross-functional sub-teams (e.g., Product, Clinical, CMC).
- Proactively identify and mitigate regulatory risks.
- Lead planning, preparation, and execution of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses.
- Represent the company in FDA and global health authority meetings; drive briefing book development, rehearsals, and moderate live meetings.
- Partner with internal teams and external vendors to ensure quality, timely, compliant submissions.
- Provide people management, coaching, and development for direct reports.
- Drive regulatory milestone and timeline accountability; escalate and resolve critical path issues.
- Manage interdependencies across programs to optimize regulatory planning and resource allocation.
- Contribute to target product labeling creation and labeling negotiations.
- Oversee core prescribing information development and product maintenance submissions.
- Ensure regulatory compliance of promotional and corporate materials.
- Collaborate with external partners (CROs, regulatory consultants, submission vendors).
- Participate in due diligence for licensing, acquisitions, and business development.
Qualifications
Basic skills:
- Bachelor’s degree in a scientific discipline required; MS/PhD/PharmD or equivalent preferred.
- 10+ years regulatory affairs experience in pharma/biotech across early-to-late development and marketing applications.
- Experience leading/participating in successful FDA and global health authority submissions and meetings.
Preferred skills:
- Strong CTD/eCTD knowledge and global regulatory requirements.
- Ability to manage strategic and operational regulatory activities.
- People management experience.
- Experience in small/start-up biotech environment; hands-on, collaborative approach.
- Strong leadership, interpersonal, communication skills to influence across functions.
- Regulatory Information System familiarity; experience developing phase-appropriate SOPs (plus).
Compensation/Benefits
- Targeted base: $246,330–$304,290. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Application instructions
None provided.
Senior Director, Regulatory Affairs to lead global regulatory strategy for vadadustat and support broader pipeline programs.
Responsibilities
- Design and lead implementation of global regulatory strategies across development programs.
- Provide strategic regulatory guidance to cross-functional sub-teams (e.g., Product, Clinical, CMC).
- Proactively identify and mitigate regulatory risks.
- Lead planning, preparation, and execution of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses.
- Represent the company in FDA and global health authority meetings; drive briefing book development, rehearsals, and moderate live meetings.
- Partner with internal teams and external vendors to ensure quality, timely, compliant submissions.
- Provide people management, coaching, and development for direct reports.
- Drive regulatory milestone and timeline accountability; escalate and resolve critical path issues.
- Manage interdependencies across programs to optimize regulatory planning and resource allocation.
- Contribute to target product labeling creation and labeling negotiations.
- Oversee core prescribing information development and product maintenance submissions.
- Ensure regulatory compliance of promotional and corporate materials.
- Collaborate with external partners (CROs, regulatory consultants, submission vendors).
- Participate in due diligence for licensing, acquisitions, and business development.
Qualifications
Basic skills:
- Bachelor’s degree in a scientific discipline required; MS/PhD/PharmD or equivalent preferred.
- 10+ years regulatory affairs experience in pharma/biotech across early-to-late development and marketing applications.
- Experience leading/participating in successful FDA and global health authority submissions and meetings.
Preferred skills:
- Strong CTD/eCTD knowledge and global regulatory requirements.
- Ability to manage strategic and operational regulatory activities.
- People management experience.
- Experience in small/start-up biotech environment; hands-on, collaborative approach.
- Strong leadership, interpersonal, communication skills to influence across functions.
- Regulatory Information System familiarity; experience developing phase-appropriate SOPs (plus).
Compensation/Benefits
- Targeted base: $246,330–$304,290. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Application instructions
None provided.