Associate Director Regulatory Affairs CMC
Akebia is currently expanding its Regulatory team to support late phase clinical assets and is searching for an Associate 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.
- 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
- Bachelor’s degree
- 6+ years pharmaceutical industry experience with a minimum of 4 years in CMC Regulatory Affairs
- Upward progression in role and leadership abilities.
- Experience leading teams or projects.
- Advanced degree in chemistry, biochemistry, or pharmacy
- Experience managing and developing direct reports
- Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages)
- Demonstrated evidence of writing of CMC regulatory documents
- Knowledge of FDA and ICH CMC regulations and guidelines a must, knowledge of EU and/or Japan CMC regulations desirable
- 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.
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Job posted: 2020-09-22