Akebia is currently expanding its Regulatory team to support of clinical development and is searching for a Director, Regulatory Affairs to support programs across all phases of development. This individual will operate in a high visibility role and will be responsible for developing and coordinating regulatory strategies and leading INDs/CTAs, Health Authority Meetings, NDA/MAAs and post-approval/life cycle management strategies. In this position, they will partner with cross-functional teams to support programs.
Design and support implementation of well-informed global regulatory strategies
Represent Regulatory Affairs on 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. US, EU, Japan)
Lead in the coordination, preparation and timely submission of regulatory documents (e.g. INDs, MAAs, NDAs).
Manage regulatory aspects for clinical studies
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
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
Experience managing and developing direct reports
Bachelor's degree in life sciences discipline
Leading preparation of an NDA and MAA strongly preferred
Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages)
Strong project management skills and drive for excellence
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.
Telecommuting is allowed.
Internal Number: 9R-99
About Akebia Therapeutics
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