Sr. Director, Regulatory Affairs Cambridge, MA

Sr. Director, Regulatory Affairs

Regulatory Affairs

Cambridge, MA

ID : 25A-15

Full-Time / Regular

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 :

Akebia is currently expanding its Regulatory team to support early and late-stage assets and is searching for a Senior Director, Regulatory Affairs to support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This individual will operate in a high visibility role and will be responsible for developing and coordinating regulatory strategies and leading IND / CTA and sNDA / NDA preparation and submissions to regulatory agencies. This position reports to the Vice President, Regulatory Affairs.

Essential Functions & Duties

• Design and support implementation of well-informed global regulatory strategies
• Represent Regulatory Affairs on project sub-teams (e.g., Product Team, Clinical Team, etc.) and provide regulatory strategy and guidance (e.g. protocol reviews, report reviews, development plans)
• Liaise with and lead the preparation, as well as meetings with Regulatory Health Authorities (e.g. U.S., E.U, Japan)
• Lead the coordination, preparation and timely submission of regulatory documents (e.g. briefing documents, pediatric plans, INDs, NDAs)
• Manage, mentor, and develop direct reports, who may lead their own development programs
• Write regulatory documents (e.g. pediatric plans, briefing documents) to support regulatory agency submissions
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Maintain knowledge of US, EU and ROW regulatory requirements and ensure compliance with regulatory requirements
• Articulate complex issues and strategic recommendations concisely and effectively across all stakeholders including senior leaders
• Develop approaches and solutions to achieve business critical goals and / or mitigate risks

Skills & Experience

Compensation :

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

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 : www.akebia.com

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.