Associate Director - Regulatory Operations

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 Regulatory interactions and submissions.
• Provide hands-on document formatting, report-level publishing, compilation, and troubleshooting support when needed.

Information Governance and Regulatory Systems

• Own the organization and maintenance of Regulatory content in SharePoint and Veeva RIM, establishing a clear information architecture, taxonomy, metadata, naming and versioning conventions, access controls, retention practices, and archival standards.
• Create an intuitive, reliable source of truth for regulatory submissions, health authority correspondence, questions, commitments, and other critical records, with a focus on inspection-ready retrieval and appropriate access.
• Serve as a RIM business or system administrator and provide direct support to content owners, functional teams, and program teams.
• Lead change management and support validation activities for GxP computerized systems, driving consistent and effective use of Regulatory systems and tools.

Operational Visibility and Continuous Improvement

• Build dashboards, calendars, metrics, and portfolio views that make submission milestones, health authority commitments, workload, dependencies, risks, and Regulatory team contributions visible to stakeholders and leadership.
• Identify and implement practical digital, automation, and workflow improvements that reduce manual effort, strengthen quality, and improve the end-to-end content and submission process.
• Translate operational data into clear updates and recommendations that support prioritization, resource planning, and timely decisions.
• Develop collaborative relationships with internal stakeholders, business partners, consultants, and vendors; manage contracts, budgets, and invoices as needed.

Perform other Regulatory Operations duties as assigned

Skills & Experience

Required Qualifications:

• BA/BS degree (advanced degree is preferred)
• 7+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Operations.
• Knowledge and understanding of the drug development process.
• Thorough knowledge of eCTD, validation criteria, data standards, submission standards, and applicable regulatory requirements.
• Hands-on experience with regulatory information management or electronic document management systems and with health authority question and commitment tracking.
• Strong project management skills, with the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks.
• Clear, collaborative communication and the judgment to analyze complex issues, build productive stakeholder relationships, and recommend practical solutions.
• High attention to detail, highly organized, flexibility, and accountability
• Commitment to Akebia's core values, culture, vision, and mission
• Experience with Veeva RIM authoring and publishing
• Experience designing SharePoint information architecture and document governance for regulated content.
• Experience with document formatting and authoring templates, and training colleagues on business processes, RIM or EDMS practices, and submission standards.
• Experience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools.
• Experience managing consultants, vendors, contracts, budgets, or invoices.
• Able to demonstrate flexibility and accountability and identify potential issues and mitigate risks
• Able to work with strategic deadlines and adapt quickly to changing requirements and priorities
• Strong written and oral communication skills
• Strong interpersonal skills
• Strong project management skills and drive for excellence