At a Glance
- Tasks: Lead strategic oversight of regulatory technology systems and ensure operational excellence.
- Company: Join a global leader in life sciences with a focus on innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with travel opportunities to engage with global stakeholders.
- Why this job: Make a real impact by ensuring regulatory platforms run smoothly and efficiently.
- Qualifications: 15-20 years in regulatory or life sciences, with strong tech and leadership skills.
The predicted salary is between 100000 - 130000 £ per year.
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
- 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.
Director - Regulatory Platforms in Maidenhead employer: CSL
As an Associate Director in Procurement Enablement at CSL, you will be part of a forward-thinking organisation that prioritises sustainability and governance while fostering a culture of continuous improvement and talent development. With a commitment to employee growth through the Global Procurement Academy and a collaborative work environment, CSL offers a unique opportunity to influence procurement practices on a global scale, making it an excellent employer for those seeking meaningful and impactful careers.
StudySmarter Expert Advice🤫
We think this is how you could land Director - Regulatory Platforms in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CSL.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CSL. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
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We think you need these skills to ace Director - Regulatory Platforms in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CSL that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CSL!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CSL, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CSL
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CSL’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
