Sr. Director, Regulatory Affairs - CMC

Akebia Therapeutics • Cambridge, MA

93d • $246,330 - $304,290

About The Position

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.

Requirements

• Bachelor's degree.
• 8+ years pharmaceutical industry experience in CMC Regulatory Affairs.
• Experience managing and developing direct reports.

Nice To Haves

• 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.

Responsibilities

• 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.
• Ensure compliance with regulatory requirements.

Benefits

• Health care.
• Vision.
• Dental.
• Retirement.
• PTO.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees