Director Regulatory Affairs CMC
Akebia is searching for a Director, Regulatory Affairs CMC to support programs in all phases of development and life-cycle management. This individual will be responsible for developing and implementing high-quality Regulatory CMC plans to enable continued compliance in multiple regions. 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. The individual will manage the preparation of high-quality CMC submissions to regulatory agencies. This position reports to the Vice President, Regulatory Affairs.
- 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
- Bachelor’s degree
- 8+ years pharmaceutical industry experience with a minimum of 5 years in CMC Regulatory Affairs
- Upward progression in role and leadership abilities. 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.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Akebia for any position posted on our career page must have a current Akebia agency agreement executed by a member of the Human Resource Department. In addition, agencies may only submit candidates to positions for which they have been invited to do so by an Akebia Recruiter. All resumes submitted outside of these terms will not be considered.
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Job posted: 2020-09-22