Lead - Regulatory Information Management
1 giorno fa
Lead - Regulatory Information Management 1 day ago Be among the first 25 applicants This role is for one of the Weekday's clients. Minimum experience: 8 years. Location: Europe. Job type: 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. Seniority level Mid-Senior level Employment type Full-time Job function Other Industries IT Services and IT Consulting #J-18808-Ljbffr
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Lead - Regulatory Information Management
2 settimane fa
roma, Italia Weekday AI (YC W21) A tempo pienoLead - Regulatory Information Management1 day ago Be among the first 25 applicantsThis role is for one of the Weekday's clients. Minimum experience: 8 years. Location: Europe. Job type: full-time.We are seeking an experienced Veeva Regulatory Information Management (RIM) professional with strong expertise in Ennov to lead and support global regulatory...
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Lead - Regulatory Information Management
2 settimane fa
roma, Italia Weekday AI A tempo pienoThis role is for one of the Weekday's clientsMin Experience: 8 yearsLocation: EuropeJobType : full-timeWe 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...
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Senior RIM Lead: Veeva
24 ore fa
Roma, Italia Weekday AI (YC W21) A tempo pienoA leading consulting firm is seeking a Lead - Regulatory Information Management professional with 8-12 years of experience. The role focuses on managing regulatory data and implementing Veeva RIM systems while ensuring compliance with global health authority requirements. The ideal candidate will leverage their expertise in Ennov and regulatory processes to...
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Regulatory Strategy Associate Director
6 giorni fa
Roma, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate Director Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company. The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities. Main...
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Regulatory Strategy Associate Director
7 giorni fa
Roma, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate Director Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company. The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities. Main...
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Regulatory Strategy Associate Director
7 giorni fa
Roma, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate Director Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company. The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities. Main...
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Regulatory Strategy Associate Director
5 giorni fa
Roma, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate Director Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company. The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities. Main...
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Remote Information Management Lead
2 giorni fa
Roma, Italia World Food Programme A tempo pienoA leading humanitarian organization is looking for an Information Management Developer and IT Manager to enhance the Relief Item Tracking Application (RITA) and support the Logistics Information Exchange platform. This role requires a strong background in software development, project management, and data analytics, with a focus on improving systems for...
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Regulatory Strategy Associate Director
5 giorni fa
roma, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate DirectorJefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company.The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities.Main...
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Regulatory Strategy Manager
6 giorni fa
Roma, Italia Jefferson Wells Italia A tempo pienoA leading biopharmaceutical company is seeking a Regulatory Strategy Associate Director to lead global regulatory strategies for complex development programs. The role involves defining regulatory pathways, guiding submission preparations, and engaging with health authorities. Candidates should possess 8-10 years of experience in Regulatory Affairs, strong...
