Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts.
Akebia is currently expanding its Regulatory team to support late phase clinical and marketed assets and is searching for an Associate Director, Regulatory Affairs. This individual will operate in a high visibility role and will be responsible for representing Regulatory Affairs in cross-disciplinary project teams, developing and coordinating regulatory strategies for assigned program(s), and manage high-quality submissions to regulatory agencies.
- Propose and design well-informed global regulatory strategies
- Represent Regulatory Affairs on project sub-teams and provide regulatory guidance to project teams (e.g. protocol reviews, report reviews, development plans)
- Support and lead in the preparation for regulatory agency meetings (e.g. US, EU, other global agencies)
- Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages)
- Write/review regulatory documents to support regulatory submissions
- Manage regulatory aspects of Phase 3 and other clinical trials concurrently
- Coordinate with internal and external partners for on-time delivery of high-quality regulatory submissions to regulatory agencies
- Establish relevant processes and procedures to support activities of the Regulatory Affairs function
- Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU, and global regulatory requirements
- Ensure compliance with regulatory requirements
- Master's degree 6 years pharmaceutical industry experience with 3 years in Regulatory Affairs
- Bachelor's degree 8 years pharmaceutical industry experience 5 years in Regulatory Affairs
- Advanced degree in life sciences
- Experience leading/working on regulatory submissions (e.g., INDs, briefing packages, NDA, MAA)
- Demonstrated evidence of writing of regulatory documents (e.g., Module 1, Module 2, briefing packages, response documents, pediatric plans, response documents, etc.)
- Knowledge of US, EU, and global regulatory requirements
- Strong knowledge of drug development
- Excellent written and oral communication skills
- Excellent interpersonal skills
- Strong project management skills and drive for excellence.