CSL
Director - Regulatory Platforms
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Director, Regulatory Platforms
The Director, Regulatory Platforms holds strategic oversight and operational accountability for the technology systems that power CSL's Global Regulatory Affairs and Safety organisation — including Regulatory Information Management, Submissions Management, Submissions Archive, Publishing, Labelling, Regulatory Intelligence, and Collaboration. This is a role that sits at the intersection of regulatory operations and technology execution: understanding not just how these platforms work, but how they need to work for a regulatory organisation to function without friction.
Based in Maidenhead, UK (Hybrid, 3 days a week)
Why It Matters
Regulatory technology is invisible when it works and immovable when it doesn't. Submissions have deadlines that don't move for system downtime, and inspectors expect validated, audit-ready environments as a matter of course. This role exists to make sure that reliability is never in question — serving as the primary digital business partner to the Head of Regulatory Operations and Global Regions, and as the escalation point when platforms need to flex, scale, or simply hold steady under pressure.
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What You'll Be Responsible For
- Own the strategic roadmap for regulatory platforms and the technology relationship with senior business leaders, translating regulatory strategy into technology that's fit for purpose.
- Provide overall leadership and accountability for regulatory platforms supporting Global Regulatory Affairs & Safety (GRAS), owning the roadmap across multiple business areas.
- Serve as primary technical and operational escalation point for the Regulatory organisation, resolving issues quickly and minimising disruption.
- Ensure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated GxP environments.
- Oversee vendor-provided technologies and outsourced application management support.
- Drive lifecycle management of platforms — upgrades, enhancements, cloud evolution, and reduction of technical debt.
- Establish platform governance, documentation standards, and operating processes that ensure long-term sustainability and audit readiness.
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Experience Required
- Bachelor's degree in Computer Science, Information Systems, Engineering, Biostatistics, Pharmaceutical Sciences, Life Sciences, or a related discipline; an advanced degree is preferred but not required.
- 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.
- PV / safety experience would also be advantageous.
Approximately 10–15% travel, domestic and occasional international, to support global stakeholders, vendors, and programme needs.
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