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?
Akebia is currently expanding its Regulatory team to support late phase clinical assets and is searching for an Associate Director, Regulatory Affairs CMC 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
- Bachelors 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.
Preferred Qualifications:
- 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
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.
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.
Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.
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 factors prohibited by law.