UPSA

Global Regulatory Affairs Assistant – EU Coordination

UPSA

full-time

Posted on:

Location Type: Hybrid

Location: Rueil-Malmaison • 🇫🇷 France

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Job Level

Mid-LevelSenior

About the role

  • Lead the end-to-end global planning of maintenance activities related to EU procedures: oversight, tracking, workload distribution, and timely submissions
  • Prepare and manage the review of common documentation packages with all relevant stakeholders, per plan
  • Ensure accurate data entry, tracking, and follow-up in the RIM tool for preparation, submission, responses to authority questions, and final European approvals
  • Guarantee clear communication flows and systematic archiving of regulatory activities
  • Contribute to the development, update, and optimization of related processes, procedural documents, and training materials
  • Support critical data review and compliance analysis for MRP/DCP/WS/SG procedures
  • Collaborate with the Global Operations Team to ensure the accuracy, completeness, and compliance of MRP/DCP registration data in line with RIM requirements and EU regulatory standards (IDMP)
  • Monitor and report KPIs for EU Regulatory activities
  • Support the onboarding and training of newcomers within the department
  • Coordinate budget tracking, vendor contracts, and related administrative follow-up
  • Organize and facilitate team meetings, workshops, and cross-functional exchanges, including the preparation and distribution of meeting minutes
  • Reports to the Innovation & EU Regulatory Affairs Director; role is non-executive and central to EU coordination

Requirements

  • 2 to 3 years of higher education
  • Minimum 5 years experience in a similar role in assisting a regulatory team with EU coordination (NP, MRP, DCP, WS, SG)
  • Solid knowledge and hands-on experience with RIM systems
  • French & English fluency (both written & spoken)
  • Proficiency with standard IT tools (Word, Excel, PowerPoint, Outlook, SharePoint)
  • Strong organizational and coordination abilities with a reliable sense of urgency and prioritization
  • Proactive, curious and dynamic
  • Previous experience in budget and vendor management is a plus
  • Position is non-executive

ATS Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
RIM systemsEU regulatory standardsMRPDCPWSSGdata reviewcompliance analysisdocumentation managementbudget management
Soft skills
organizational abilitiescoordination abilitiessense of urgencyprioritizationproactivecuriousdynamiccommunicationteam facilitationtraining
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