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Director, Regulatory Affairs CMC

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Akebia Therapeutics Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Akebia is searching for a Director, Regulatory Affairs CMC tosupport programs in all phases of development and life-cyclemanagement. This individual will be responsible for developing andimplementing high-quality Regulatory CMC plans to enable continuedcompliance in multiple regions. The individual will haveresponsibility for managing CMC-related components of productdevelopment and commercialization (e.g., drug substance, drugproduct, packaging/distribution), as well as for representingRegulatory Affairs on CMC and Program teams and with partners. Theindividual will manage the preparation of high-quality CMCsubmissions to regulatory agencies. This position reports to theVice President, Regulatory Affairs.

Required Skills Lead the preparation of high-quality CMCsections for regulatory submissions including for INDs, IMPDs, theJapanese NDA (JNDA), US NDA, MAAs, and briefing packages

Manage and mentor Regulatory CMC direct reports as assigned

Write CMC regulatory documents to support regulatory submissionsusing industry best practices and internal Akebia standards

Propose and design well-informed global CMC regulatorystrategies (US, EU, and Japan)

Represent Regulatory Affairs on CMC and Program teams and withpartners

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 QAcolleagues, as well as external Contract ManufacturingOrganizations (CMOs) to document and resolve technicalmanufacturing issues under compliance with cGMPs

Assist in the preparation for regulatory agency meetings on CMCtopics

Maintain knowledge of global CMC regulatory requirements andadvise internal stakeholders on emerging CMC regulatory trends

Coordinate on-time delivery of high-quality regulatorysubmissions to regulatory agencies

Establish relevant processes and procedures to supportRegulatory Affairs function activities

Participate in regulatory intelligence gathering activities andmaintain knowledge of global CMC regulatory requirements

Ensure compliance with all regulatory requirements

Required Experience Basic Qualifications:

8+ years pharmaceutical industry experience with a minimum of 5years in CMC Regulatory Affairs

Upward progression in role and leadership abilities. Leadingteams 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

Akebia Therapeutics, Inc. is a fully integratedbiopharmaceutical company focused on the development andcommercialization of therapeutics for people living with kidneydisease. The Company was founded in 2007 and is headquartered inCambridge, Massachusetts. For more information, please visit ourwebsite at www.akebia.com

Akebia Therapeutics is an equal opportunity employer andwelcomes all job applicants. All qualified applicants will receiveconsideration for employment without discrimination on the basis ofrace, color, religion, sex, sexual orientation, gender identity,national origin, protected veteran status, disability, or any otherfactors prohibited by law.

Keywords: Akebia Therapeutics Inc., Cambridge , Director Regulatory Affairs CMC, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director, Regulatory Affairs CMC, Other , Cambridge, Massachusetts

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