Lead - Regulatory Information Management

3 giorni fa

WorkFromHome, Italia Weekday AI A tempo pieno

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 . #J-18808-Ljbffr

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