Role Description UBC is currently recruiting within our Regulatory team for a Regulatory Operations Manager in either France or the Netherlands with multi-country experience in Regulatory Ethics Submission experience. - Lead the creation of regulatory documents, processes, and the development of regulatory strategy to achieve regulatory approvals and clearances worldwide expediently and consistently within all studies, interventional and non-interventional. - Write and submit regulatory and/or technical documents with minimal review from senior staff for assigned projects. - Act as Regulatory Lead for complex projects/programs or for mentoring junior staff. - Provide regulatory expertise to clinical project teams and clients (e.g., CTA applications, importation of clinical trial material, reporting of adverse events). - May be responsible for the registration and/or publication of clinical trial/study related information on clinical trial databases. - Develop the regulatory application strategy, including submission requirements, associated costs, and time schedules necessary to achieve global project approvals as required by the project plan in a timely and cost-effective manner. - May develop and/or review regulatory SOPs and other guidance required for delivering regulatory operations. - Responsible for process implementation and ensure process compliance within the regulatory Operations team. - Develop and maintain internal regulatory intelligence by proactively investigating, analyzing, and capitalizing on key regulatory regulations, legislations, and guidance at local, regional, and global levels. - Create high-quality reports and other outputs according to the defined specifications to ensure timely reporting of metrics to regulatory management or designee. - Provide robust regulatory and/or technical information to support key sponsor regulatory project milestones. - Serve as worldwide technical expert on relevant regulatory issues potentially impacting the study. - Propose, in line with the business timelines, the 1–5-year regulatory studies and activities budget, specifying quality standards to be met, and making best use of UBC’s resources. - Develop professional relationships with MoH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations. - Provide country-specific regulatory expertise to customers and clinical operations teams. - May participate in bid defence meetings to present regulatory deliverables and provide strategic advice, at the discretion of senior staff. - May supervise, train, and mentor junior regulatory affairs team members, including providing feedback on the quality of technical documents. - Other duties as assigned by EU Director Clinical Regulatory Operations/designee or UBC Management. - 10% travel availability. Qualifications - Master’s degree in life science-related discipline or professional equivalent plus 3-5 years’ regulatory experience pertinent to clinical trials, non-interventional studies, and/or registries. - Demonstrates comprehensive regulatory expertise including preparation and submission of CTAs, the applications for import licenses, and any reporting procedures. - Recognized expertise in regulatory affairs including thorough knowledge of international guidelines and regulations applicable to clinical research (e.g. GCP, GVP, GEP/GPP, EUCTR…). - Very strong organization, planning, and budget tracking abilities to handle potentially conflicting multiple portfolio projects. - Strong leadership abilities to unite diverse groups to a common task and strategy. - Excellent verbal and written communication skills to collaborate with and discuss technical information and regulatory requirements with project teams and governmental agencies. - Expertise with information management technology (e.g., archiving databases, document editing software, statistical manipulation of data). - Demonstrated networking ability and negotiation skills to work within sponsor and government systems building expert networks and applying them to address business needs. - Ability to work effectively with lengthy project review periods. - Flexibility, adaptability, diplomacy, and ability to overcome complexity. - Respect for and understanding of cultural diversity. - Ability to successfully work in a ‘virtual’ team environment. - Fluent in English. - Ability to work with all levels of management. - Ability to travel internationally and domestically. - General computer proficiency including Microsoft Word, Excel, Access, Internet, and experience with document tracking tools.

• Lead Planning & Setup, Monitoring, and Closeout phases of study management. • Gather customer requirements and communicate expectations to internal teams. • Develop study documentation and manage equipment distribution and tracking. • Create and distribute study reports; archive study documentation according to standards. • Monitor study timelines, conduct budget reviews, forecast revenue, and manage scope changes and invoice reconciliation. • Identify study risks, propose mitigations, and escalate issues as appropriate. • Manage internal and external negotiations to promote strong collaboration and efficient resource use. • Apply structured problem‑solving strategies to resolve customer issues using documented issue‑tracking processes. • Present study services at Investigator Meetings or site initiation meetings as needed. • Attend client meetings with Business Development or operational teams to represent services and workflows. • Ensure training completion and documentation compliance. • Support onboarding and training of new Project Management team members. • Perform additional duties and special projects as needed.

• Lead and manage Projects in accordance with Mitel’s goals and processes • Launch new Projects to support the organizational strategic direction using Agile Methodologies • Facilitate project teams and stakeholder’s communication to promote teamwork and collaboration • Ensure project success criteria meets specification/requirements and establish a project schedule and plan • Direct teams and individuals to project schedules, identify risks and risk mitigation to deliver on-time and within resource capacity • Track technical issues and find solutions for project problems as they arise to deliver a superior customer experience • Utilize organization skills to manage multiple facets of a project and track progress for several projects concurrently • Recognize and coordinate appropriate escalations regarding project issues and decisions • Implement, manage, and track changes to ensure project goals are achieved • Produce accurate and timely reporting of Project status throughout its life cycle • Support identification of organizational & business improvement opportunities • Develop knowledge of Mitel products, systems, software, hardware, and applications

• act as partner with sales and account teams to support RFPs, technical proposals, and solution presentations. • lead the delivery and design of scalable Web Commerce, BSS, and B2B Marketplace solutions. • Conduct client discovery workshops to identify requirements and propose viable solution architectures. • perform strategic leadership and technical depth to guide multidisciplinary teams through digital transformation initiatives. • act as Subject Matter Expert (SME) in B2B commerce models and Marketplace architectures, with hands-on experience designing end-to-end systems that span e-commerce, partner/vendor onboarding, multi-tenant catalogs, order orchestration, and BSS integration (CRM, billing, provisioning).