Regulatory Systems and Process Optimisation Lead
Bayer
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Regulatory Systems and Process Optimisation Lead
This role helps build Consumer Health’s Veeva Vault RIM system, connected regulatory data and priority processes into a trusted, AI-ready backbone for Regulatory Affairs and the broader Science Home. It also supports process improvement across connected systems such as PDV, an SAP-based system where Regulatory-owned processes or data are impacted. Working within DTO and contributing through the cross-functional Regulatory Affairs Processes & Special Topics (RAPS) work team, it uses continuous customer and end-user engagement to turn Veeva Vault RIM data signals, process pain points and strategic priorities into practical improvements that meet current and future organisational needs. The aim is simple: reduce manual effort, improve confidence and return expert capacity to strategy, innovation, growth and commercial outcomes.
Your Tasks and 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.
Your Skills and 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 supporting training, stakeholder engagement, cross-functional adoption and customer-led process improvement.
- 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 in