Director, Regulatory Data Management (Boston, MA)

Role: Lead the strategy, governance, and execution of regulatory data management within Vertex’s Regulatory Information Management System (RIMS). Objectives include ensuring data accuracy, quality, completeness, and inspection readiness of critical regulatory information to support compliance, decision-making, and audit preparedness. Responsibilities involve managing and developing a team of regulatory data professionals, establishing data governance standards, overseeing data processes for regulatory documentation, and driving continuous improvements in data integrity and usability. The role also includes leading reporting metrics for senior management and stakeholder engagement across functions. Requirements include a bachelor’s degree (preferably in life sciences or technology), at least 10 years of experience in a pharmaceutical/biotech environment with 3+ years in leadership, and expertise in GxP, regulatory information management, and change management. Key skills encompass stakeholder management, project organization, communication, analytical capabilities, and personnel management. High-value biopharma specifics: experience with regulatory data, inspection readiness, and compliance within a biotech or pharma setting, potentially involving biologics or small molecules, with a focus on regulatory documentation and audit support. Work setup is hybrid or on-site, with flexible work arrangements.