Director - Regulatory Platforms

About the role

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 role sits at the intersection of regulatory operations and technology execution, ensuring these platforms function seamlessly for the regulatory organisation. Based in Maidenhead, UK (Hybrid, 3 days a week).

Regulatory technology is critical: submissions have fixed deadlines, and inspectors expect validated, audit-ready environments. This role ensures reliability, 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 adapt or scale under pressure.

Responsibilities

• Own the strategic roadmap for regulatory platforms and the technology relationship with senior business leaders, translating regulatory strategy into fit-for-purpose technology.
• Provide overall leadership and accountability for regulatory platforms supporting Global Regulatory Affairs & Safety (GRAS), owning the roadmap across multiple business areas.
• Serve as the primary technical and operational escalation point for the Regulatory organisation, resolving issues quickly to minimise 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 — including upgrades, enhancements, cloud evolution, and reduction of technical debt.
• Establish platform governance, documentation standards, and operating processes to ensure long-term sustainability and audit readiness.

Requirements

• Bachelor's degree in Computer Science, Information Systems, Engineering, Biostatistics, Pharmaceutical Sciences, Life Sciences, or a related discipline; an advanced degree is preferred.
• 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.
• Pharmacovigilance (PV) / safety experience is advantageous.
• Approximately 10–15% travel, domestic and occasional international, to support global stakeholders, vendors, and programme needs.

About CSL Behring

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 immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms — plasma fractionation, recombinant protein technology, and cell and gene therapy — to support continued innovation and refine ways to address unmet medical needs.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries.

Benefits

For more information on CSL benefits, visit How CSL Supports Your Well-being.