Associate Director, Regulatory Operations

Role: Associate Director, Regulatory Operations, leading global regulatory submission planning, content management, and process improvement at Akebia, with a focus on compliance and systems readiness. Responsibilities: oversee end-to-end submission processes, manage regulatory information systems (SharePoint, Veeva RIM), develop standard operating procedures, ensure readiness for eCTD 4.0, and enhance operational visibility through dashboards and metrics. Provide strategic and hands-on leadership to optimize regulatory workflows, document governance, and change management, supporting clinical development and post-market activities, primarily in a regulated environment with GxP considerations. Requirements: BA/BS (advanced degree preferred), 7+ years in pharmaceutical/biotech Regulatory Operations, extensive knowledge of eCTD, regulatory data standards, and RIM systems, with proven project management, stakeholder engagement, and process design skills. Experience with Veeva RIM, SharePoint architecture, and regulatory content formatting is essential. Preferred: experience with regulatory submissions in life cycle management, systems validation, and digital automation. High-value specifics include global regulatory coordination, focus on health authority interactions (notably US), and systems validation in a GxP context. Work setup: hybrid in Waltham, MA, with regular onsite presence.