Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

Regulatory Affairs

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.

**We are open to REMOTE applicants on the East Coast**

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

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:

Akebia is entering an exciting phase of growth as we advance a portfolio of innovative therapies aimed at transforming the lives of patients with chronic kidney disease and related conditions. We are seeking a Senior Director, Regulatory Affairs to play a critical leadership role in shaping the global regulatory strategy for vadadustat and advancing our broader pipeline programs, including rare kidney diseases.

This is a highly visible and impactful position, offering the opportunity to influence development programs from early through late-stage, guide key regulatory interactions, and help bring meaningful therapies to patients with significant unmet need. The Senior Director will serve as a strategic partner across functions, driving regulatory excellence while balancing speed, risk, and long-term value creation.

In this role, you will lead the development and execution of global regulatory strategies, oversee IND/CTA and NDA/sNDA submissions, and represent Regulatory Affairs in cross-functional decision-making. Reporting to the Vice President, Regulatory Affairs, you will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization.

Responsibilities:

* Regulatory Strategy & Leadership

o Design and lead implementation of global regulatory strategies across development programs.

o Provide strategic regulatory guidance on cross-functional sub-teams (e.g., Product, Clinical, CMC).

o Proactively identify and mitigate regulatory risks to ensure alignment with business objectives.

* Regulatory Submissions & Health Authority Interactions

o Lead the planning, preparation, and execution of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses.

o Represent the company in meetings with FDA and global health authorities; drive briefing book development, lead rehearsals, and moderate live meetings.

o Partner with internal teams and external vendors to ensure quality, timely, and compliant regulatory submissions.

* Team & Program Leadership

o Provide people management, coaching, and development for direct reports, enabling growth and success.

o Drive team accountability for regulatory milestones and timelines; escalate and resolve critical path issues.

o Actively manage interdependencies across programs to optimize regulatory planning and resource allocation.

* Labeling, Compliance & Lifecycle Management

o Contribute to target product labeling creation and regulatory labeling negotiations.

o Oversee core prescribing information development and product maintenance submissions.

o Ensure regulatory compliance of promotional and corporate materials in alignment with regulatory expectations.

* Cross-functional Engagement & Vendor Management

o Collaborate with external partners (CROs, regulatory consultants, and submission vendors) to support program needs.

o Participate in due diligence activities for licensing, acquisitions, and other business development efforts.

Qualifications:

Basic skills:

• Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• 10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with demonstrated experience across early to late-stage development and marketing applications.
• Experience leading or participating in successful FDA and global health authority submissions and meetings.

Preferred skills;

• Strong working knowledge of CTD/eCTD structure and global regulatory requirements.
• Demonstrated ability to manage both strategic and operational aspects of regulatory activities.
• People management experience required, with a demonstrated ability to lead and mentor others.
• Experience operating in a small or start-up biotech environment, with a hands-on and collaborative approach.
• Strong leadership, interpersonal, and communication skills, with ability to influence across functions and levels.
• Regulatory Information System familiarity and experience developing phase-appropriate SOPs a plus.

Compensation:

Targeted Base: $246,330 - $304,290*

*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.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website:

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 characteristics protected by applicable law.