Associate Director, Regulatory Operations

Waltham, 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?

Please note that our offices have recently relocated to Waltham, MA. 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

The Associate Director, Regulatory Operations is a hands-on leader who will shape how Akebia plans, produces, submits, and manages regulatory information. In addition to leading timely, high-quality global submissions, this role will have meaningful influence over the processes, standards, and systems that enable Regulatory Affairs to operate effectively.

The successful candidate will establish scalable ways of working, strengthen document governance across SharePoint and Veeva RIM, help lead the company's readiness for eCTD 4.0, and introduce practical tools and reporting that make the Regulatory team's priorities, progress, and impact visible across the company. This opportunity is well suited to someone who enjoys combining submission expertise with systems thinking, change leadership, and hands-on execution.

This role is based in Waltham, MA in a hybrid model. Applicants must be able to come to office on a regular basis. The role reports to the Senior Director, Regulatory Affairs.

Key Responsibilities:

Strategic Leadership and Process Design

• Provide strategic and operational leadership for Regulatory Operations, helping set functional direction, plan and build capabilities, and deliver timely, high-quality submissions.
• Shape and continuously improve Regulatory Operations processes, governance, roles, handoffs, and quality controls so the function can scale with company needs.
• Develop and maintain standard operating procedures, training materials, job aids, and other practical resources that support consistent execution across teams

Submission Operations and eCTD readiness

• Lead end-to-end submission planning, publishing and archival of global regulatory filings supporting clinical development, clinical development, product registration, and post-approval product maintenance.
• Manage submission activities internally and with business partners and third-party vendor, including schedules, dependencies, quality checks, and delivery risks.
• Serve as an system administrator for RIM system and provide direct support to functional disciplines and program teams responsible for developing submission contents
• Manage day-to-day submission activities both internally and in collaboration with business partners, including 3 rd party vendors
• Organize, archive and track Health Authority (HA) correspondences, submissions, and questions/commitments globally, primary focus on the US
• Partner with Regulatory Leads to develop submission plans and timelines, maintain the submission calendar, and coordinate content from functional disciplines and program teams
• Help lead company readiness for eCTD 4.0 by monitoring requirements, assessing gaps, and developing a practical transition roadmap for systems, metadata, processes, validation, vendor capabilities, training, and change management.
• Provide project management support in generation of timelines for…