Sr. Director, Regulatory Affairs - CMC
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CMC / Technical Operations
Cambridge, MA
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ID:
25R-19
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Full-Time/Regular
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?
Job Description:
Akebia is searching for a Senior 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 Vice President, Regulatory Affairs.
Essential Functions & Duties
* Work cross functionally to develop and execute global CMC regulatory strategies for investigational and commercial products.
* Manage, mentor and develop Regulatory CMC direct reports as assigned
* 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
* Write CMC regulatory documents to support regulatory submissions using industry best practices and internal Akebia standards
* Develop and implement high-quality Regulatory CMC plans to enable continued compliance in multiple regions
* 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
* Participate in regulatory intelligence gathering activities and maintain knowledge of global CMC regulatory requirements
* Coordinate 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
Skills & Experience
Basic Qualifications:
* Bachelor's degree
* 8+ years pharmaceutical industry experience in CMC Regulatory Affairs
* Experience managing and developing direct reports
Preferred Qualifications:
* Advanced degree in chemistry, biochemistry, or pharmacy
* 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
Compensation:
Targeted Base: $246,330 - $304,290*
*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
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. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com
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 characteristics protected by applicable law.
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