Lead - Regulatory Information Management at Weekday AI

We are redirecting you to the source. If you are not redirected in 3 seconds, please click here.

Lead - Regulatory Information Management at Weekday AI. This role is for one of the Weekday's clients. Min Experience: 8 years. Location: Europe. JobType: full-time. We are seeking an experienced . Veeva Regulatory Information Management (RIM) professional. with strong expertise in . Ennov. to lead and support global regulatory operations and system implementations. The ideal candidate will play a critical role in managing end-to-end regulatory information, ensuring compliance with global health authority requirements, and driving digital transformation initiatives across regulatory systems.. This role requires a deep understanding of regulatory processes, hands-on experience with Veeva RIM modules, strong Ennov knowledge, and the ability to work cross-functionally with Regulatory Affairs, IT, Quality, and external partners.. Key Responsibilities. Lead and support . Veeva RIM implementations, enhancements, and ongoing operations. , including modules such as RIM Submissions, RIM Registrations, RIM Publishing, and RIM Archive. . Act as a . subject matter expert for Ennov. , supporting regulatory document management, publishing, submissions, and lifecycle management activities. . Manage . global regulatory data. including product registrations, submissions, variations, renewals, and commitments across multiple regions (US, EU, APAC, LATAM). . Collaborate with Regulatory Affairs teams to . define business requirements. , translate them into system configurations, and ensure alignment with regulatory processes. . Drive . data quality, governance, and compliance. within Veeva RIM and Ennov systems. . Support . system integrations. between Veeva RIM, Ennov, and other enterprise systems (e.g., ERP, Quality, Clinical systems). . Provide leadership in . process optimization and standardization. , leveraging best practices in regulatory information management. . Lead or support . user acceptance testing (UAT). , validation activities, SOP creation, and end-user training. . Ensure systems and processes comply with . global regulatory standards and guidelines. (FDA, EMA, MHRA, PMDA, etc.). . Act as a key point of contact for . vendors, system partners, and internal stakeholders. . . Mentor junior team members and provide guidance on regulatory systems and tools. . Required Skills & Qualifications. . 8–12 years of experience. in Regulatory Information Management or Regulatory Operations within life sciences (pharma, biotech, medical devices). . Strong hands-on experience with . Veeva RIM. (Submissions, Registrations, Publishing, Archive). . . Strong expertise in Ennov. (Publishing, Submissions, Regulatory DMS, or related modules). . Solid understanding of . regulatory submission processes. and health authority requirements. . Experience working in . GxP-compliant environments. with system validation exposure. . Excellent stakeholder management, communication, and documentation skills. . Ability to work in global, cross-functional, and matrixed environments. . Nice to Have. Experience with . Veeva Vault platform configurations. . . Exposure to . data migration. , system upgrades, or large-scale RIM transformations. . Prior experience in . lead or solution architect roles. . . Company Location: France.