Regulatory Information Management
- RIM 1. Requirement in easy terms We are looking for Regulatory Operations / Regulatory Information Management professionals with 1 to 5 years of relevant experience. The key message for sourcing is: Source for hands-on RIM experience, not generic Regulatory Affairs experience. Candidates should demonstrate actual system-based RIM activities such as DER processing, regulatory event/submission creation, registration lifecycle maintenance, regulatory data updates, quality checks, reconciliation and Health Authority correspondence. The requirement specifically covers DERs, Registration Objects, Submission Objects, Veeva RIM data management and registration lifecycle activities. High priority Veeva Vault RIM / Veeva RIM Regulatory Information Management or Regulatory Operations DER / Data Entry Request processing Registration Objects / registration records Submission Objects / submission records Regulatory event and submission creation Registration lifecycle management Regulatory data creation, update and maintenance Data quality checks, reconciliation and validation Health Authority correspondence Global regulatory submission/registration exposure Good additional experience xEVMPD IDMP SPOR / PMS Product Detail Set Renewals, variations, approvals, transfers and withdrawals eCTD Regulatory data governance Reporting / regulatory analytics 3. Sample CVs CV 1: Relevant experience includes: M.




Pharm in Regulatory Affairs 4+yrs exp Regulatory Affairs Associate supporting EU markets Hands-on Veeva Vault RIM (GRIDS) and Global Insight xEVMPD submissions Product Detail Set updates Product registration data maintenance Renewals, new MA approvals and cancellations Data migration and system maintenance in Veeva Vault RIM and PMS [RHY_CV.pdf | PDF] CV 2: Relevant experience includes: 1 year of Regulatory Operations experience Regulatory data management RIMS event and submission creation Initial/new registration activities License and Product Detail Set updates Submission results and approval updates xEVMPD and IDMP submissions Health Authority correspondence Data quality checks eCTD publishing Veeva Vault plus other regulatory systems CV 3: Relevant experience includes: Global Regulatory Affairs experience at GSK Hands-on Veeva Vault RIM DER processing Regulatory data updates Creation and management of regulatory events and associated records Submission and product lifecycle support License transfers, cancellations and renewals QC of eCTD/non-eCTD submissions Regulatory data/process gap and CAPA analysis [Archana H__CV.pdf | PDF] Relevant profiles could potentially have titles such as: Regulatory Operations Specialist Regulatory Affairs Associate Regulatory Information Management Specialist Regulatory Data Specialist Regulatory Operations Associate Regulatory Data Management Associate

📌 Regulatory Information Management RIM (Mississauga)
🏢 Zodiac Solutions
📍 Mississauga