Regulatory Systems & Process Optimisation Lead (Remote)

Bayer; Warszawa; Remote; PLN 126,000 - 151,000; Full time

Benefits offered by this job

Supplementary medical services

Flexible benefits supporting leisure &

Life, accident, and disability保险

Job summary

Bayer in Poland seeks a Regulatory Systems and Process Optimisation Lead (remote role) to strengthen Veeva Vault RIM, connect regulatory data and priority processes into an AI-ready backbone for Regulatory Affairs and related systems.

You will own and optimise Veeva Vault RIM led processes, coordinate with SAP-based PDV, and partner with APAC and META stakeholders to drive adoption, standardisation and efficiency.

Qualifications

• 3–5+ years’ experience in regulatory operations, regulatory systems, data stewardship, submissions coordination or process improvement within pharmaceutical, consumer health or life sciences.
• Proven hands-on experience using Veeva Vault RIM in a business, regulatory operations, submissions, data stewardship or process optimisation capacity, including document management, master data, metadata, workflows, lifecycles, regulatory data and end-user support; Veeva certification advantageous.
• Working knowledge of Lean Six Sigma, process mapping, root-cause analysis, continuous improvement and benefit tracking.
• Experience coordinating vendors, service providers or support teams in regulated digital environments; awareness of automation, analytics, AI readiness, data integrity and inspection readiness.
• Applied experience of Regulatory Affairs and the drug development process, regulatory document management, Veeva Vault RIM, metadata, document lifecycles, master data, submissions and inspection-readiness expectations, demonstrated through hands-on contribution to process, system or data outcomes.
• Strong process ownership, data stewardship and user experience mindset, with the ability to map ways of working, identify manual hand-offs, share insights and design scalable improvements across shared ownership models.
• Fluent in written and spoken English, with strong business communication, facilitation, stakeholder engagement and technical writing skills to make complex process, data and system topics clear, practical and engaging for global audiences.
• Applied experience with automation, AI tools, prompting techniques, GxP change management, validated system change control, UAT and digital adoption, demonstrated through practical delivery or improvement outcomes.
• Able to work independently within agreed direction, collaborate across shared ownership models, influence without formal authority and translate business needs into practical system, data and process improvements.
• Confident using Microsoft Teams, Word, Excel, PowerPoint, SharePoint, MS Copilot and Azure DevOps, and resourceful in using Veeva Connect, customer forums and cross-team networks to share knowledge.

Responsibilities

• Regulatory data and Veeva Vault RIM foundation: Improve how documents, metadata and connected data are structured, governed and used through Veeva Vault RIM as the primary regulatory platform, supporting compliance, inspection readiness, business decisions, Active Dossier, automation and AI, while considering connected systems such as SAP-based PDV where Regulatory processes or data span both.
• Process ownership and optimisation: Own and improve assigned Veeva Vault RIM-led process areas, currently user tasks and workflows, labelling, risk management plan submissions, PSUR and PBRERs, and submission management, including touchpoints with SAP-based PDV where relevant. Simplify, standardise and modernise these processes with customers, aligned to RAPS priorities for harmonised RA processes and process authoring excellence.
• Customer partnership and insight: Act as the regular DTO contact for assigned customer communities, currently APAC and META, using monthly engagement to understand regional needs, adoption barriers, training requirements and improvement opportunities. Use walkthroughs and ongoing dialogue with relevant end users to ensure solutions reflect real work, maximise impact and support current and future organisational priorities.
• Automation, AI readiness and value realisation: Identify where structured data, standardised processes, prevention controls, automation or AI can reduce effort, improve quality, lower service-provider cost and return time to teams. Routinely validate and quantify impact to prioritise changes and implementation timing based on business value.
• Compliance, validation and inspection readiness: Contribute to the GxP validated state of Veeva Vault RIM and related processes, including UAT, change control, CAPA/deviation inputs, audit and inspection support, service-provider governance, and RAPS priorities for training, compliance and regulatory consistency.
• Collaborative delivery and adoption: Work with stakeholders across the organisation to redesign processes, shape system and data requirements, strengthen data standards, increase adoption and deliver automation-ready improvements. Where opportunities sit outside assigned areas, share insights with the wider team or designated owner to shape solutions collaboratively.

Skills

Regulatory operations

Regulatory systems

Data stewardship

Submissions coordination

Process improvement

Tools

Veeva Vault RIM

Azure DevOps

MS Copilot

Veeva Connect

SharePoint

Job description

Bayer in Poland seeks a Regulatory Systems and Process Optimisation Lead (remote role) to strengthen Veeva Vault RIM, connect regulatory data and priority processes into an AI-ready backbone for Regulatory Affairs and related systems.

You will own and optimise Veeva Vault RIM led processes, coordinate with SAP-based PDV, and partner with APAC and META stakeholders to drive adoption, standardisation and efficiency.