DT Solution Expert Regulatory Submissions
Il y a 3 jours
Anderlecht, Brussels, Belgique
UCB
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We are looking for a Digital Technology Solution Expert Regulatory Submissions who is collaborative, solution‑driven and curious to join us in our Digital Technology Regulatory team, based in our HQ office in Brussels, Belgium.
About The Role
This global role within UCB’s Digital Technology organization is accountable for the technical ownership and lifecycle management of Digital Technology systems and services supporting the regulatory submissions & registrations. Acting as Digital Technology System Owner (DTSO) for supporting Veeva Vault RIM and adjacent technologies, the role is accountable for ensuring system availability, performance, security, maintainability, and scalability. It drives the sustained technical performance and evolution of the system, in alignment with the vendor product evolution, user and data requirements, and applicable regulatory obligations. This global function supports applications subject to GxP regulatory requirements and is based in Belgium. Who you’ll work with You will act as the primary Digital Technology point of contact with a strong regulatory affairs acumen, working in close partnership with Functional System Owners, Data Owners, Process owners and Domain Lead, Veeva Integration Lead and Veeva COE. Operating with a high level of autonomy and accountability, the DTSO oversees the system administration and ensures effective incident, change, and problem management. You will partner with colleagues across integration, security, compliance and enterprise platforms to ensure solutions work seamlessly and remain compliant. This role requires strong communication, partnership and the ability to navigate a diverse and international environment. What You’ll Do Manage projects and change requests to deliver high‑quality solutions on time and within agreed budgets ensuring effective use of allocated resources (including external service providers, contractors, and financial budgets) and adherence to agreed timelines. Provide technical and architectural expertise to lead solution design, configuration development and implementation, and ensures that systems remain compliant with applicable GxP requirements, including validation (acting as DTSO), data integrity, and cybersecurity controls. Ensure systems are operated and maintained in a compliant and validated state, in line with applicable regulatory requirements (e.g., GxP), including data integrity, cybersecurity, and audit/inspection readiness. Collaborate closely with Functional System Owners (FSO), Data Owners, and Process Owners within regulatory stakeholders to understand business needs and translate them into effective, scalable, and cost‑efficient Digital Technology solutions, aligned with UCB governance, architecture principles, and strategic priorities. Partners with both transversal and horizontal DT teams and subject matter experts to explore, prototype, and industrialize solutions (e.g., proof of concepts), leveraging internal capabilities or external strategic partners as appropriate. Act as a key technical interface with strategic vendors to ensure Source (Veeva) capabilities evolve in line with UCB requirements, maximizing value delivery and alignment with business and regulatory expectations Provide expert input into strategy, roadmap, and investment planning, ensuring alignment between technology capabilities and business priorities. Maintain a strong understanding of industry trends, emerging technologies, and digital innovation to continuously enhance system capabilities and drive modernization of the technology landscape. Interested? For this role we’re looking for the following education, experience and skills Bachelor’s or Master’s degree in a scientific, technical, digital or related field Expertise in Veeva Vault ideally Vault RIM At least 2 years of experience in managing projects within a DT/Digital environment. Experience in life sciences industry is considered a plus. Fluent in English, any other language is a plus Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Requisition ID: 94013 Recruiter: Leonor de la Vega Hiring Manager: Morad Tahani Talent Partner: Britta Gotsch Job Level: MM II Please consult HRAnswers for more information on job levels.
About The Role
This global role within UCB’s Digital Technology organization is accountable for the technical ownership and lifecycle management of Digital Technology systems and services supporting the regulatory submissions & registrations. Acting as Digital Technology System Owner (DTSO) for supporting Veeva Vault RIM and adjacent technologies, the role is accountable for ensuring system availability, performance, security, maintainability, and scalability. It drives the sustained technical performance and evolution of the system, in alignment with the vendor product evolution, user and data requirements, and applicable regulatory obligations. This global function supports applications subject to GxP regulatory requirements and is based in Belgium. Who you’ll work with You will act as the primary Digital Technology point of contact with a strong regulatory affairs acumen, working in close partnership with Functional System Owners, Data Owners, Process owners and Domain Lead, Veeva Integration Lead and Veeva COE. Operating with a high level of autonomy and accountability, the DTSO oversees the system administration and ensures effective incident, change, and problem management. You will partner with colleagues across integration, security, compliance and enterprise platforms to ensure solutions work seamlessly and remain compliant. This role requires strong communication, partnership and the ability to navigate a diverse and international environment. What You’ll Do Manage projects and change requests to deliver high‑quality solutions on time and within agreed budgets ensuring effective use of allocated resources (including external service providers, contractors, and financial budgets) and adherence to agreed timelines. Provide technical and architectural expertise to lead solution design, configuration development and implementation, and ensures that systems remain compliant with applicable GxP requirements, including validation (acting as DTSO), data integrity, and cybersecurity controls. Ensure systems are operated and maintained in a compliant and validated state, in line with applicable regulatory requirements (e.g., GxP), including data integrity, cybersecurity, and audit/inspection readiness. Collaborate closely with Functional System Owners (FSO), Data Owners, and Process Owners within regulatory stakeholders to understand business needs and translate them into effective, scalable, and cost‑efficient Digital Technology solutions, aligned with UCB governance, architecture principles, and strategic priorities. Partners with both transversal and horizontal DT teams and subject matter experts to explore, prototype, and industrialize solutions (e.g., proof of concepts), leveraging internal capabilities or external strategic partners as appropriate. Act as a key technical interface with strategic vendors to ensure Source (Veeva) capabilities evolve in line with UCB requirements, maximizing value delivery and alignment with business and regulatory expectations Provide expert input into strategy, roadmap, and investment planning, ensuring alignment between technology capabilities and business priorities. Maintain a strong understanding of industry trends, emerging technologies, and digital innovation to continuously enhance system capabilities and drive modernization of the technology landscape. Interested? For this role we’re looking for the following education, experience and skills Bachelor’s or Master’s degree in a scientific, technical, digital or related field Expertise in Veeva Vault ideally Vault RIM At least 2 years of experience in managing projects within a DT/Digital environment. Experience in life sciences industry is considered a plus. Fluent in English, any other language is a plus Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Requisition ID: 94013 Recruiter: Leonor de la Vega Hiring Manager: Morad Tahani Talent Partner: Britta Gotsch Job Level: MM II Please consult HRAnswers for more information on job levels.