Director - Regulatory Platforms
HybridBerkshire, Virginia, United States
Job Summary
Own the strategic roadmap for regulatory platforms powering CSL's Global Regulatory Affairs and Safety organization, translating regulatory strategy into technology fit for purpose. Provide overall leadership and accountability for systems including Regulatory Information Management, Submissions Management, Archive, Publishing, Labelling, and Regulatory Intelligence. Serve as the primary technical and operational escalation point for the regulatory organization, resolving issues quickly to minimize disruption. Ensure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated GxP environments. Oversee vendor-provided technologies, drive lifecycle management including upgrades and cloud evolution, and establish governance standards for long-term sustainability. This role sits at the intersection of regulatory operations and technology execution, ensuring reliability is never in question for global submissions.
Required Qualifications
- Bachelor's degree in Computer Science, Information Systems, Engineering, Biostatistics, Pharmaceutical Sciences, Life Sciences, or a related discipline
- 15–20 years of experience working with regulatory organisations, R&D, or the life sciences industry
- Direct experience with Veeva Vault Regulatory systems
- Working knowledge of regulatory operations, submissions and publishing, and the technology that supports them
- Strong experience operating within GxP settings, including system validation, inspection readiness, and data integrity
- Proven ability to partner with senior leadership to deliver technology solutions
- Approximately 10–15% travel, domestic and occasional international, to support global stakeholders, vendors, and programme needs
Desired Qualifications
- an advanced degree is preferred but not required
- PV / safety experience would also be advantageous
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