Regulatory Operations Lead — Submissions & Systems (Hybrid)

Akebia Therapeutics, Inc.; Waltham (MA); Hybrid; USD 168,000 - 207,000; Full time

Benefits offered by this job

Company bonus program

Equity

Health care

Vision & dental

Job summary

Akebia Therapeutics, Inc. in Waltham, MA is seeking an Associate Director, Regulatory Operations to lead global submissions and shape governance for regulatory information management.

This hands-on leader will implement scalable processes, drive eCTD readiness, and provide system admin support for SharePoint and Veeva RIM, while reporting to the Senior Director, Regulatory Affairs. Hybrid work with regular in-office presence is required; base salary range is $167,650–$207,098, with equity and

Qualifications

• BA/BS degree (advanced degree preferred).
• 7+ years in regulatory operations within pharma/biotechnology.
• Thorough knowledge of eCTD, validation criteria, data standards and submission requirements.
• Hands-on experience with regulatory information management or electronic document management systems and with HA tracking.
• Strong project management skills with deadlines, priorities and risks.
• Clear, collaborative communication and stakeholder relationship building.
• Attention to detail, organization, flexibility and accountability.

Responsibilities

• Provide strategic leadership for Regulatory Operations and deliver timely, high-quality submissions.
• Lead end-to-end submission planning, publishing, and archival of global filings.
• Own RIM governance: SharePoint/Veeva content, metadata, naming/versioning.
• Lead change management and validation activities for GxP systems.
• Build dashboards and portfolio views to track milestones, commitments and risks.
• Develop and maintain SOPs, templates and training materials for consistent execution.

Skills

Regulatory Operations leadership

Project management

Regulatory information management

Systems thinking

Communication

Change leadership

Stakeholder management

Education

BA/BS degree

Advanced degree preferred

Tools

Veeva RIM

SharePoint

EDMS

Smartsheet/Microsoft 365

Job description

Akebia Therapeutics, Inc. in Waltham, MA is seeking an Associate Director, Regulatory Operations to lead global submissions and shape governance for regulatory information management.

This hands-on leader will implement scalable processes, drive eCTD readiness, and provide system admin support for SharePoint and Veeva RIM, while reporting to the Senior Director, Regulatory Affairs. Hybrid work with regular in-office presence is required; base salary range is $167,650–$207,098, with equity and