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 searching for a Director, Regulatory Affairs CMC to lead the regulatory CMC activities for our programs across all phases of development and life-cycle management.
The individual will have responsibility for managing CMC-related components of product development and commercialization (e.g., drug substance, drug product, packaging/distribution), as well as for representing Regulatory Affairs on CMC and Program teams and with partners.
This position reports to the Sr Director, Regulatory Affairs CMC
Required Skills
- Lead the preparation of high-quality CMC sections for regulatory submissions including for INDs, IMPDs, the Japanese NDA (JNDA), US NDA, MAAs, and briefing packages
- Manage and mentor Regulatory CMC direct reports as assigned
- Write CMC regulatory documents to support regulatory submissions using industry best practices and internal Akebia standards
- Propose and design well-informed global CMC regulatory strategies (US, EU, and Japan)
- Represent Regulatory Affairs on CMC and Program teams and with partners
- Provide regulatory guidance to the CMC department (e.g., stability protocols, specifications, report reviews, C of A’s, product labels, and CMC development plans)
- Collaborate with internal CMC staff, consultants, and QA colleagues, as well as external Contract Manufacturing Organizations (CMOs) to document and resolve technical manufacturing issues under compliance with cGMPs
- Assist in the preparation for regulatory agency meetings on CMC topics
- Maintain knowledge of global CMC regulatory requirements and advise internal stakeholders on emerging CMC regulatory trends
- Coordinate on-time delivery of high-quality regulatory submissions to regulatory agencies
- Establish relevant processes and procedures to support Regulatory Affairs function activities
- Participate in regulatory intelligence gathering activities and maintain knowledge of global CMC regulatory requirements
- Ensure compliance with all 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.