Regulatory Systems and Process Optimisation Lead

Drive Innovation at the Heart of Regulatory Transformation!

Warsaw-based opportunity with the possibility to work fully remote!

As a Regulatory Systems and Process Optimisation Lead you will be working for our client, a global life‑science innovator delivering therapeutics and self‑care solutions to patients worldwide through a highly regulated supply chain. Embedded in the Global Regulatory Operations team, you spearhead a strategic programme to modernise Regulatory Information Management by deploying Veeva Vault RIM and harmonising connected workflows. Your mission is to translate business needs into scalable system configurations, build robust governance around change, and cultivate a continuous‑improvement culture. By aligning technology, process and people, you enable faster, smarter decisions that accelerate product availability and enhance public health outcomes.

Your main responsibilities: Drive continuous improvement of global regulatory processes and their reflection in Veeva Vault RIM

• Maintain the validated state of RIM by coordinating change management and user acceptance testing
• Develop and update compliant process maps, SOPs and guidance documents
• Design and monitor performance metrics, flagging improvement opportunities
• Collaborate with cross‑functional teams to implement automated, lean solutions
• Facilitate training sessions and communicate best practices to end users and SMEs
• Represent Global Regulatory Operations during audits, inspections and CAPA reviews
• Govern service providers to ensure quality, timeliness and regulatory compliance

You’re ideal for this role if you have:

• At least five years of regulatory or quality experience within the pharmaceutical or self‑care sector
• Proven hands‑on expertise with Veeva Vault RIM and its validated use
• Lean Six Sigma certification or practical application experience
• Demonstrated success in change management and UAT of GxP systems
• Ability to translate complex business needs into technical requirements and vice versa
• Entrepreneurial, solution‑oriented mindset with strong analytical skills
• Advanced verbal and written communication capabilities
• Solid project management track record in a global matrix environment
• Collaborative attitude with strong customer and team orientation
• Life sciences or business degree or equivalent professional experience
• ​​​​​​​Proficiency in Teams, Word, Excel, PowerPoint, Visio, AzureDevOps (ADO) and SharePoint

#GETREADY  to meet with us!

We would like to meet you. If you are interested please apply and attach your CV in English or Polish, including a statement that you agree to our processing and storing of your personal data. You can always also apply by sending us an email at recruitment@itds.pl.

Internal number #7308