Job Description
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
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Pay Range:
$192,000 - $288,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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