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