Director - Regulatory Platforms
Appcast Enterprise · Maidenhead
Job description
About the role
The Director of Regulatory Platforms provides strategic oversight and operational accountability for the technology systems that enable CSL's Global Regulatory Affairs and Safety organisation. Based in Maidenhead on a hybrid schedule (three days onsite), the role bridges regulatory operations with technology execution to ensure platforms are reliable, audit‑ready, and aligned with business needs.
Key responsibilities
- Own and drive the strategic roadmap for all regulatory platforms, translating regulatory strategy into fit‑for‑purpose technology.
- Lead platform governance, documentation standards, and operating processes to guarantee long‑term sustainability and audit readiness.
- Serve as the primary technical and operational escalation point for the regulatory organisation, resolving issues swiftly to minimise disruption.
- Oversee vendor‑provided technologies and outsourced application management, ensuring compliance with GxP, data integrity, security and inspection‑readiness requirements.
- Manage platform lifecycle activities including upgrades, enhancements, cloud migration and technical debt reduction.
Required profile
- Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences or related discipline (advanced degree preferred).
- 15–20 years of experience within regulatory organisations, R&D or the life‑sciences industry.
- Direct experience with Veeva Vault Regulatory systems.
- Strong knowledge of regulatory operations, submissions, publishing and the supporting technology.
- Extensive experience working in validated GxP environments, including system validation and inspection readiness.
Required skills
- Veeva Vault Regulatory platforms
- GxP compliance and system validation
- Cloud platform migration and management
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Published 1 month ago
Expires 2 weeks from now
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Appcast Enterprise
Maidenhead