Director, Regulatory Data Management (Boston, MA)
Vertex Pharmaceuticals
August 18, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Director, Regulatory Data leads the strategy, governance, execution, and continuous improvement of regulatory data management within Vertex’s Regulatory Information Management System (RIMS), ensuring accurate collection, maintenance, quality oversight, reporting, and inspection readiness of critical regulatory data and documentation.
Key Duties and Responsibilities:
- Lead Regulatory Data Management: vision, operating model, priorities, and performance expectations for governance, data quality, and reporting.
- Manage, coach, and develop a team of regulatory data professionals.
- Oversee RIMs data and documentation processes for accurate collection, entry, maintenance, and reporting.
- Ensure regulatory data quality and completeness with controls, monitoring, metrics, and escalation pathways.
- Establish and maintain regulatory data governance standards (ownership, definitions, quality expectations, documentation, accountability).
- Drive inspection and audit readiness; ensure data/documentation/evidence are complete, accurate, traceable, and retrievable; support inspections and audits.
- Lead regulatory data reporting and metrics delivery to senior management and stakeholders.
- Drive continuous improvement to strengthen data integrity and usability.
- Identify and mitigate regulatory data risks (incomplete data, inconsistent documentation, unclear ownership, process gaps).
- Ensure onboarding, training, and capability building.
Knowledge and Skills:
- Leadership experience in Regulatory information management/GxP data.
- Stakeholder management, change management, project/time/resource management.
- Strong attention to detail; ability to manage multiple complex projects.
- Communication/influencing across all organizational levels.
- Cross-functional priority setting; excellent analytical skills.
- Personnel management (internal FTEs and/or vendor management).
Education and Experience:
- Bachelor’s degree (preference life sciences or technology).
- Typically 10 years in a pharmaceutical/biotech technology area and 3 years supervisory/management experience (or equivalent).
The Director, Regulatory Data leads the strategy, governance, execution, and continuous improvement of regulatory data management within Vertex’s Regulatory Information Management System (RIMS), ensuring accurate collection, maintenance, quality oversight, reporting, and inspection readiness of critical regulatory data and documentation.
Key Duties and Responsibilities:
- Lead Regulatory Data Management: vision, operating model, priorities, and performance expectations for governance, data quality, and reporting.
- Manage, coach, and develop a team of regulatory data professionals.
- Oversee RIMs data and documentation processes for accurate collection, entry, maintenance, and reporting.
- Ensure regulatory data quality and completeness with controls, monitoring, metrics, and escalation pathways.
- Establish and maintain regulatory data governance standards (ownership, definitions, quality expectations, documentation, accountability).
- Drive inspection and audit readiness; ensure data/documentation/evidence are complete, accurate, traceable, and retrievable; support inspections and audits.
- Lead regulatory data reporting and metrics delivery to senior management and stakeholders.
- Drive continuous improvement to strengthen data integrity and usability.
- Identify and mitigate regulatory data risks (incomplete data, inconsistent documentation, unclear ownership, process gaps).
- Ensure onboarding, training, and capability building.
Knowledge and Skills:
- Leadership experience in Regulatory information management/GxP data.
- Stakeholder management, change management, project/time/resource management.
- Strong attention to detail; ability to manage multiple complex projects.
- Communication/influencing across all organizational levels.
- Cross-functional priority setting; excellent analytical skills.
- Personnel management (internal FTEs and/or vendor management).
Education and Experience:
- Bachelor’s degree (preference life sciences or technology).
- Typically 10 years in a pharmaceutical/biotech technology area and 3 years supervisory/management experience (or equivalent).