Director - Regulatory Platforms

CSL Plasma Inc.; Maidenhead; Hybrid; GBP 120,000 - 180,000; Full time

Job summary

CSL Behring seeks a Director of Regulatory Platforms to oversee the technology systems that power Global Regulatory Affairs and Safety. Based in Maidenhead, UK, this hybrid role leads the regulatory platforms strategy and collaborates with senior leaders to ensure compliant, scalable technology across GRAS.

The role requires deep experience in regulatory operations, Veeva Vault, and GxP environments, with a track record of delivering robust, audit-ready solutions.

Qualifications

• Needs to lead regulatory platforms strategy and execution.
• Experience partnering with senior leaders to deliver technology solutions.
• Strong knowledge of regulatory operations, submissions, publishing, and data integrity.
• Experience operating in GxP environments with validation and inspection readiness.
• Willingness to travel domestically and occasionally internationally.

Responsibilities

• Own the strategic roadmap for regulatory platforms and align with regulatory strategy.
• Provide leadership and accountability for platforms across GRAS and related areas.
• Serve as primary escalation point for regulatory technology issues to minimise disruption.
• Ensure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated environments.
• Oversee vendor-provided technologies and outsourced application management.
• Drive lifecycle management: upgrades, cloud evolution and reducing technical debt.
• Establish governance, documentation standards and operating processes for sustainability.

Skills

Leadership

Regulatory platforms

Stakeholder management

Biotech/Life sciences domain knowledge

Regulatory operations

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault Regulatory

Job description

About the 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.

What You'll Be Responsible For

You’ll 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.

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.

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 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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

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

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.

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