Director Regulatory Platforms

The Director Regulatory Platforms holds strategic oversight and operational accountability for the technology systems that power CSLs 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 doesnt. Submissions have deadlines that dont 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.

What Youll Be Responsible For

Youll own the strategic roadmap for regulatory platforms and the technology relationship with senior business leaders translating regulatory strategy into technology thats 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

Experience Required

• Bachelors degree in Computer Science Information Systems Engineering Biostatistics Pharmaceutical Sciences Life Sciences or a related discipline; an advanced degree is preferred but not required
• 1520 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 1015% travel domestic and occasional international to support global stakeholders vendors and programme needs.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

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Director