04 Nov
|
AceStack
|
Mississauga
04 Nov
AceStack
Mississauga
Regulatory Information Management (RIM) Primary Skills: Veeva Vault RIM, Regulatory Information Management, Regulatory Operations Job Type: Full-time Location: Mississauga, ON | Hybrid Job Description We are seeking a Regulatory Information Management (RIM) professional with 1 5 years of relevant experience in Regulatory Operations or Regulatory Information Management.
The ideal candidate will have hands-on experience managing regulatory data, registration records, submission records, and product lifecycle activities using Veeva Vault RIM or other regulatory information management systems.
Candidates must have practical experience in system-based RIM activities rather than general Regulatory Affairs experience.
Key Responsibilities: Process Data Entry Requests (DERs) and manage regulatory data updates in Veeva Vault RIM.
Create and maintain regulatory events, submission records, registration objects, and submission objects.
Support registration lifecycle activities, including recent registrations, renewals, variations, approvals, transfers, and withdrawals.
Perform regulatory data creation, maintenance, reconciliation, and quality checks to ensure accuracy and completeness.
Manage product registration data, licenses, and Product Detail Sets.
Support Health Authority correspondence and maintain regulatory records in accordance with applicable requirements.
Assist with global regulatory submissions and registration activities.
Support data validation, migration, and system maintenance activities.
Ensure regulatory information is accurate, consistent, and up to date across systems.
Required Skills and Qualifications: 1 5 years of relevant experience in Regulatory Operations, Regulatory Information Management, or Regulatory Data Management.
Hands-on experience with Veeva Vault RIM or a similar regulatory information management system.
Practical experience processing DERs and managing registration and submission records.
Knowledge of regulatory event creation, submission creation, and registration lifecycle management.
Experience with regulatory data maintenance, quality checks, reconciliation, and validation.
Understanding of global regulatory submissions and Health Authority processes.
Strong attention to detail and data accuracy.
Preferred Skills: Experience with xEVMPD, IDMP, SPOR/PMS, and Product Detail Sets.
Knowledge of eCTD submissions and regulatory data governance.
Experience supporting regulatory renewals, variations, approvals, transfers, and withdrawals.
Familiarity with regulatory reporting and analytics.
Education: Bachelor's or Master's degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field preferred.
📌 Regulatory Information Management- RIM (Mississauga)
🏢 AceStack
📍 Mississauga