Akebia is currently expanding its Regulatory team to support late phase clinical assets and is searching for a Director, Regulatory Affairs to support the continued development of vadadustat in the treatment of anemia.  This individual will operate in a high visibility role and will be responsible for developing and coordinating regulatory strategies and leading NDA/MAA preparation and submission to regulatory agencies.  In this position, they will partner with the Clinical, Medical, Program Management and Alliance Management groups to move this work forward.

Required Skills

• Design and support implementation of well-informed global regulatory strategies
• Represent Regulatory Affairs on vadadustat project sub-teams and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans)
• Support and lead in the preparation of meetings with Regulatory Health Authorities (e.g. U.S., E.U)
• Lead in the coordination, preparation and timely submission of regulatory documents (e.g. INDs, MAAs, NDAs).
• Manage regulatory aspects of Phase 3 and other clinical trials concurrently
• Manage, mentor, and develop direct reports
• Write regulatory documents to support regulatory agency submissions
• Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
• Ensure compliance with regulatory requirements

Required Experience

Basic Qualifications:

• Bachelor's degree
• Minimum of 8 years pharmaceutical industry experience with a minimum of 5 years in Regulatory Affairs
• Specific experience working on a successful NDA and/or MAA
• Upward progression in role and leadership abilities.  Leading teams or projects.

Preferred Qualifications:

• Bachelor's degree in life sciences discipline
• Advanced degree 
• Leading preparation of an NDA and MAA strongly preferred
• Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages)
• Demonstrated evidence of writing regulatory documents (Module 1, Module 2, briefing packages)
• Knowledge of US and EU regulatory requirements
• Knowledge of drug development
• Excellent written and oral communication skills
• Excellent interpersonal skills
• Strong project management skills and drive for excellence

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com

Akebia Therapeutics 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 factors prohibited by law.

AGENCY AND THIRD PARTY RECRUITER NOTICE:

Agencies that submit a resume to Akebia for any position posted on our career page must have a current Akebia agency agreement executed by a member of the Human Resource Department.  In addition, agencies may only submit candidates to positions for which they have been invited to do so by an Akebia Recruiter. All resumes submitted outside of these terms will not be considered.

• Design and support implementation of well-informed global regulatory strategies
• Represent Regulatory Affairs on vadadustat project sub-teams and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans)
• Support and lead in the preparation of meetings with Regulatory Health Authorities (e.g. U.S., E.U)
• Lead in the coordination, preparation and timely submission of regulatory documents (e.g. INDs, MAAs, NDAs).
• Manage regulatory aspects of Phase 3 and other clinical trials concurrently
• Manage, mentor, and develop direct reports
• Write regulatory documents to support regulatory agency submissions
• Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
• Ensure compliance with regulatory requirements