Manager Regulatory Affairs, CMC

Akebia Therapeutics•Cambridge, MA

4h•Hybrid

About The Position

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 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. 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.

Requirements

Bachelor's degree in life sciences required
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)
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

Nice To Haves

Advanced degree preferred
Experience with Regulatory information Management systems (e.g., Veeva RIM preferred)

Responsibilities

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.
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.
Support regulatory assessments of CMC changes, deviations, and CAPAs.
Oversee timely execution of variations and supplements across regions.
Implement review, approval, and submission processes.
Maintain regulatory tracking tools and data.
Contribute to SOP development and regulatory process documentation.