Regulatory Systems and Process Optimisation Manager

Bayer CropScience Limited; Województwo pomorskie; On-site; PLN 158,000 - 190,000; Full time

Benefits offered by this job

Supplementary medical services

Flexible benefits

Life insurance

Pension plans

Home office allowance

Additional paid leave

Job summary

Bayer CropScience Limited is looking for a Regulatory Systems and Process Optimisation Manager to join their team in Gdańsk, Poland. This role involves strategic leadership in regulatory capabilities, particularly concerning Veeva Vault RIM and cross-system integrations.

Candidates should have at least 5 years of experience in regulatory affairs, with a strong focus on process optimisation and stakeholder engagement.

Qualifications

• Minimum 5 years of experience in regulatory affairs or operations within pharmaceutical, consumer health, or life sciences.
• Proven expertise in using and optimising Veeva Vault RIM.
• Strong experience leading cross-functional regulatory process initiatives.

Responsibilities

• Define regulatory processes and automation capabilities.
• Lead strategic roadmaps and initiatives aligned to business objectives.
• Own business-side integration mapping for Veeva Vault RIM.
• Optimise regulatory processes across connected systems.
• Coordinate business-side progression of solutions via Azure DevOps.
• Lead training and implementation planning for new capabilities.
• Represent Bayer on IDMP and related industry forums.

Skills

Regulatory affairs

Veeva Vault RIM

Process optimisation

Automation

Stakeholder engagement

Data stewardship

Cross-functional leadership

GxP compliance

Continuous improvement

AI-enabled solutions

Education

5+ years in regulatory operations

Tools

Azure DevOps

SAP-based PDV

Job description

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 Manager

Your Tasks and Responsibilites

• Strategic capability leadership: Define and evolve Veeva Vault RIM-led regulatory processes, data, automation and AI-enabled capabilities that are scalable, compliant and user-friendly. Current focus areas include IDMP and XEVMPD within Veeva Vault RIM, alongside process optimisation involving SAP-based PDV where Regulatory-owned processes or data span systems, ensuring cross-system needs are understood, prioritised and delivered with IT and business SMEs.
• Roadmap, outcomes and value: Shape strategic roadmaps and priority initiatives aligned to business objectives, regulatory requirements and DTO priorities. Own outcomes, remove blockers and use quantified impact to focus delivery on the highest-value opportunities.
• Business-side Veeva Vault RIM integration mapping: Lead business-side integration mapping for systems connecting to Veeva Vault RIM, with activity flexing according to business priorities. Ensure process, data, integration requirements and system dependencies are understood, harmonised and optimised. Work with business SMEs, system SMEs, IT and technical stakeholders to clarify needs, shape requirements, support testing, prepare for go- live and continuously iterate integrations as business needs evolve.
• Cross-system process optimisation: Lead optimisation of regulatory processes spanning Veeva Vault RIM, SAP-based PDV and other connected systems where relevant, identifying opportunities to simplify, harmonise, automate and improve ways of working while maintaining clear business-side ownership of requirements, priorities and outcomes.
• Co-created solution delivery: Own the business-side progression of Veeva Vault RIM process, data and system changes through Azure DevOps, with input from end users, customers, DTO, IT, technical stakeholders and system SMEs. Ensure requirements, clarifications, validation, testing, UAT and implementation readiness are coordinated, and that solutions are user-friendly, automation-ready and AI-enabled where appropriate.
• Implementation readiness and adoption: Lead initial training, implementation readiness and adoption planning for new capabilities, maintaining oversight of future improvements.
• External readiness and industry foresight: Represent Bayer on IDMP and related industry forums, including Telematics/AESGP where relevant. Translate emerging regulatory data, integration and industry changes into proactive roadmaps, plans and communications.
• Compliance and continuous improvement leadership: Assess regulatory guidance changes for their impact on processes, systems, training and compliance, ensuring changes are RESTRICTED reflected compliantly in regulatory systems and embedded through a continuous improvement culture using customer insight, data quality signals, automation/AI opportunities and quantified business impact.

Your Skills and Qualifications

• 5+ years' experience in regulatory affairs, regulatory operations, regulatory systems, quality, data stewardship, process optimisation or digital transformation within pharmaceutical, consumer health or life sciences.
• Proven hands-on experience using and optimising Veeva Vault RIM, including regulatory data, master data, metadata, document management, workflows, lifecycles, submissions, Veeva Vault RIM integration touchpoints and related business processes; able to translate business requirements into system, data and process improvements.
• Experience leading cross-functional regulatory process, data, system or transformation initiatives with measurable business outcomes.
• Experience progressing changes through Azure DevOps or equivalent delivery models, including requirements shaping, solution validation, UAT, implementation readiness and GxP compliance.
• Experience with automation and AI-enabled process or data improvement, ideally including implementation, solution design or applied business use.
• Experience engaging senior stakeholders, service providers, IT partners, business SMEs and external industry forums across global or matrixed organisations.
• Proven experience of end-to-end Regulatory Affairs processes, submissions, regulatory data, Veeva Vault RIM, master data, metadata, document management, compliance and inspection readiness.
• Strong business-side process, data and cross-system mapping capability, anchored in Veeva Vault RIM and covering data flows, dependencies, interfaces, business rules, integration touchpoints with connected systems and SAP-based PDV process optimisation opportunities.
• Demonstrated ability to set direction, own outcomes, influence continuous improvement and lead cross-functional initiatives that deliver measurable value.
• Fluent in written and spoken English, with strong business communication, facilitation, stakeholder engagement and technical writing skills to translate business and technical needs into clear requirements, delivery priorities and understandable change requests for Azure DevOps, IT and implementation partners. RESTRICTED
• Applied experience with IDMP, XEVMPD, automation, AI-enabled process improvement, GxP change management, validated system change control and UAT, demonstrated through practical delivery, adoption or improvement outcomes.
• Solution-focused, creative and self-propelling, with an entrepreneurial mindset, strong future focus and excellent senior stakeholder engagement skills.

The minimum gross monthly salary for this role is 15 600 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.

• 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)

Location: Poland : Pomorskie : Gdańsk

Division: Enabling Functions

Reference Code: 878706

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 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.