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Manager Regulatory Affairs, CMC (TEST)

Cambridge, Massachusetts, United States
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?
This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.
 

Job Summary:

Akebia is building a highly collaborative, science-driven team committed to improving the lives of patients with kidney disease and beyond. As we expand our portfolio across early and late-stage programs, we are looking for a Manager, Regulatory Affairs CMC who will thrive in a team-oriented, solutions-focused environment and is looking to play a visible, hands-on role in shaping regulatory strategy and execution. This role will support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This is an exciting opportunity to directly influence regulatory outcomes and product success. This position reports to the Sr. Director, Regulatory Affairs CMC.

Essential Functions and Duties

Strategy

  • Implement global CMC strategy for assigned programs.
  • Collaborate with cross-functional teams to assess the regulatory impact on CMC related issues
  • Lead CMC-focused regulatory projects.
  • Understand regulatory risk and phase appropriate approaches.

Authoring and Submission Excellence

  • Author and compile CMC modules for INDs/IMPDs/CTAs; NDAs/BLAs/MAAs; amendments, supplements, and variations.
  • Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality teams to ensure clear, consistent, and high-quality submissions using Regulatory eCTD templates.
  • Support global submission, amendments, supplements, and responses to health authority information requests.
  • Evaluate change controls for CMC impact across Akebia owned filings.

Lifecycle & Change Management

  • Support regulatory assessments of CMC changes, deviations, and CAPAs.
  • Oversee timely execution of variations and supplements across regions.

Process Building

  • Implement review, approval, and submission processes.
  • Maintain regulatory tracking tools and data.
  • Contribute to SOP development and regulatory process documentation.

Basic Qualifications

  • Bachelor's degree in life sciences required; advanced degree preferred
  • 5+ years Regulatory Affairs CMC experience in the pharmaceutical/biotech industry
  • Experience supporting high-quality, global submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages)
  • Experience with Regulatory information Management systems (e.g., Veeva RIM preferred)
  • Strong project management and organizational skills, including coordinating team and managing timelines for regulatory submissions.
  • Demonstrated ability to author CMC documents and manage cross-functional inputs
  • Strong understanding of US and EU regulatory requirements
  • Knowledge of drug development for both small molecule and biologics
  • Excellent written and oral communication skills with a collaborative, team-first mindset
  • Excellent interpersonal skills

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.

Targeted Base Salary

$139,672 - $172,536 USD

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 factors prohibited by law.

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