Regulatory Systems and Process Optimisation Lead

Bayer CropScience Limited; Województwo pomorskie; On-site; PLN 126,000 - 151,000; Full time

Benefits offered by this job

Home office allowance

Supplementary medical services

Flexible benefits

Job summary

Bayer in Poland is seeking a Regulatory Systems and Process Optimisation Lead to build and optimise the Veeva Vault RIM backbone and integrate connected regulatory data for efficient regulatory affairs and growth.

The role focuses on process improvement across SAP-based PDV and other systems, driving automation, AI readiness, and inspection readiness while collaborating with cross-functional teams to deliver practical, scalable solutions.

Qualifications

• 3–5+ years in regulatory operations, regulatory systems, data stewardship or process improvement.
• Hands-on experience using Veeva Vault RIM in regulatory operations or data stewardship.
• Lean Six Sigma and process-mapping experience.
• Experience coordinating vendors or service providers in regulated environments.

Responsibilities

• Improve regulatory data and Veeva Vault RIM foundation, structuring and governance of documents and metadata.
• Own and optimise Veeva Vault RIM-led process areas including submission management and PSUR/PBRERs.
• Engage with customer communities (APAC/META) to understand regional needs and adoption barriers.
• Identify automation or AI opportunities to reduce effort and improve quality.
• Contribute to validation, inspection readiness and training within GxP contexts.

Skills

Veeva Vault RIM knowledge

Lean Six Sigma

Regulatory operations

Stakeholder engagement

Tools

Veeva Vault RIM

SAP PDV

Job description

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 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.

At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices.

The minimum gross monthly salary for this role is 12 400 PLN. The final salary will be determined based on objective factors such as professional experience, qualifications, scope of responsibility.

This position is be eligible for variable pay components, such as annual or performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure.

In addition, Bayer offers a competitive and holistic benefits package, including:

• Supplementary medical services
• Flexible benefits supporting leisure and well‑being
• Life, accident, and disability insurance
• Employer‑supported pension plans
• Home office allowance to support hybrid or remote work
• Additional paid leave (if applicable)

Benefits may vary depending on role and employment conditions.

YOUR APPLICATION

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer offers the possibility of working in a hybrid model. We know how important work‑life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.

Bayer respects and applies the Whistleblower Act in Poland.

Location

Poland : Pomorskie : Gdańsk

Division

Enabling Functions

Reference Code

878707