Director Regulatory Data Strategy (Hybrid)

Vertex Inc.

Boston (MA)

Hybrid

USD 192,000 - 288,000

Full time

14 days+
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Job summary

Vertex Inc. is seeking a Director of Regulatory Data to lead strategy, governance, and execution across the Regulatory Information Management System (RIMS).

You will oversee data stewardship, drive data quality, reporting, and inspection readiness, and partner cross-functionally to support regulatory decisions and program objectives. The role requires a seasoned leader with deep experience in GxP data, stakeholder management, and change management, guiding a team to deliver reliable regulatory

Qualifications

  • Bachelor’s degree in life sciences or technology preferred.
  • 10+ years in a technology role within pharma/biotech with 3+ years in supervision.
  • Experience leading regulatory data programs and cross-functional teams.

Responsibilities

  • Lead regulatory data governance, quality, and reporting functions.
  • Manage and develop a team of regulatory data professionals.
  • Oversee data collection, entry, maintenance, and reporting from trusted sources.
  • Ensure data quality, controls, metrics, and escalation pathways.
  • Establish data governance standards and ownership models.
  • Drive inspection readiness and liaison support for audits.
  • Lead regulatory data reporting for senior management and programs.
  • Drive continuous improvement in regulatory data integrity and usability.
  • Identify and mitigate data risks and training needs.

Skills

Regulatory data governance
Leadership
Stakeholder management
Change management
Regulatory information management
Project management
Communication

Education

Bachelor's degree in life sciences or technology

Tools

RIMS (Regulatory Information Management System)

Job description

Vertex Inc. is seeking a Director of Regulatory Data to lead strategy, governance, and execution across the Regulatory Information Management System (RIMS).

You will oversee data stewardship, drive data quality, reporting, and inspection readiness, and partner cross-functionally to support regulatory decisions and program objectives. The role requires a seasoned leader with deep experience in GxP data, stakeholder management, and change management, guiding a team to deliver reliable regulatory

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