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Consultant – Regulatory Database Administrator
Ividata Life Sciences. Enter, enrich, and update product regulatory data in RIM and PMS databases .
Tech Stack
Tools & technologiesFlux
About the role
Key responsibilities & impact- Enter, enrich, and update product regulatory data in RIM and PMS databases
- Analyze and leverage source dossiers, particularly eCTD dossiers, to identify manufacturer, site, and activity data
- Verify the compliance and accuracy of data integrated into the EMA PMS database as part of the eDMP project
- Identify inconsistencies or errors between different systems and perform data-cleansing activities
- Ensure the ongoing reliability of packaging information and packaging items
- Contribute to drafting and updating standard operating procedures related to regulatory data management
- Collaborate with Regulatory Affairs and IT teams to optimize data flows and eliminate duplicate data entry
- Work on high-value projects for clients in the pharmaceutical and biotechnology sectors
Requirements
What you’ll need- Pharmacy degree (PharmD) or Master’s degree in Regulatory Affairs, Health Law, or Health Engineering
- Junior candidates with significant initial experience, an internship, or an apprenticeship in Regulatory Affairs are welcome to apply
- Strong knowledge of eCTD/CTD dossier structures
- Experience with regulatory data management tools (RIM)
- Familiarity with European standards and portals (PMS, eDMP, and preferably xEVMPD/IDMP)
- Knowledge of the pharmaceutical industry environment and EMA regulations
- Knowledge of regulatory data governance and integrity (Data Integrity)
- Rigorous approach, excellent critical thinking with regard to data, autonomy, and strong analytical and synthesis skills
- Professional fluency in French and English
Benefits
Comp & perks- Remote work opportunities
- Stimulating, collaborative, and constantly evolving environment
- High-impact assignments
- Collaboration with passionate experts
- Opportunity to make a real impact through your ideas and expertise