Director, Regulatory Data Management

General Summary:

The Director, Regulatory Data is responsible for leading the strategy, governance, execution, and continuous improvement of regulatory data management within Vertex’s Regulatory Information Management System (RIMS). This role provides leadership for the accurate collection, maintenance, quality oversight, reporting, and inspection readiness of critical regulatory data and documentation. The Director leads and develops a team responsible for regulatory data stewardship, establishes scalable processes and standards, and partners cross-functionally to ensure regulatory information is complete, reliable, inspection-ready, and positioned to support portfolio, operational, and compliance decision-making.

Key Duties and Responsibilities:

• Lead the Regulatory Data Management function, setting the vision, operating model, priorities, and performance expectations for regulatory data governance, data quality, and regulatory information reporting.
• Manage, coach, and develop a team of regulatory data professionals, including setting objectives, managing workload and priorities, supporting career development, and ensuring effective execution of team deliverables.
• Oversee RIMs data and documentation processes, ensuring accurate collection, entry, maintenance, and reporting of critical regulatory information based on approved sources of truth.
• Accountable for regulatory data quality and completeness across assigned systems and processes, ensuring appropriate controls, monitoring, metrics, and issue escalation pathways are in place.
• Establish and maintain data governance standards, including ownership models, data definitions, quality expectations, process documentation, and accountability frameworks for regulatory data stewardship.
• Drive inspection and audit readiness for regulatory information maintained in RIMs, ensuring data, documentation, processes, and evidence are complete, accurate, traceable, and readily retrievable; the source role includes responsibility for inspection readiness and liaison support for inspections and audits.
• Lead development and delivery of regulatory data reporting and metrics for senior management, governance forums, program teams, and other stakeholders, expanding the source role’s accountability for informational reports and metrics.
• Lead continuous improvement initiatives to strengthen regulatory data integrity, reduce process variation, improve system adoption, and enhance the usability of regulatory information for decision-making.
• Identify and mitigate regulatory data risks, including incomplete data, inconsistent documentation, unclear ownership, process gaps, and inspection readiness concerns.
• Ensure effective onboarding, training, and capability building for team members and stakeholders who contribute to or rely on regulatory data

Knowledge and Skills:

• Experience in a leadership role in Regulatory information management/GxP data
• Highly developed Stakeholder Management skills
• Highly skilled in change management practices
• Demonstrated skills managing project timelines and organizing resources
• Strong attention to detail and the ability to manage complex, multiple projects
• Strong communication and influencing skills throughout all levels of the organization
• Ability to establish priorities and work with cross functional groups to deliver against strategic objectives
• Excellent analytical skills'
• Experience managing personnel (internal FTEs or vendor management)

Education and Experience:

• Bachelor's degree, with a preference for life sciences or technology area
• Typically requires 10 years of experience in a technology area within a pharmaceutical/biotech company and 3 years of supervisory/management experience, or the equivalent combination of education and experience