Regulatory Information Management RIM
- Mississauga, ON, Canada
Full-time
Applications open in a new tab.
Job details
- Job type
- Full-time
- Apply by
- Experience
- 1 year of Regulatory Operations experience
- Posting language
- English
- Posted
Original job description
Regulatory Information Management- RIM
- Requirement in simple 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
- 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
More about this job
Responsibilities
Manage regulatory information in RIM systems, including DER processing, regulatory event and submission creation, registration record maintenance, and regulatory data updates. Perform data quality checks and reconciliation, support registration lifecycle activities, and handle Health Authority correspondence.
Requirements
Candidates should have 1 to 5 years of relevant Regulatory Operations or Regulatory Information Management experience, with hands-on, system-based RIM work rather than only general Regulatory Affairs experience. Experience with Veeva Vault RIM, DERs, registration and submission objects, regulatory data maintenance, and global submissions or registrations is sought; xEVMPD, IDMP, SPOR, eCTD, and lifecycle activities are additional assets.
Skills
- Veeva Vault RIM
- Regulatory Information Management
- DER Processing
- Regulatory Data Management
- Regulatory Event Creation
- Submission Creation
- Registration Objects
- Submission Objects
- Regulatory Data Quality Checks
- Data Reconciliation
- Health Authority Correspondence
- xEVMPD
- IDMP
- eCTD
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Administrative
Keywords
- Regulatory Information Management
- Regulatory Operations
- Veeva Vault RIM
- DER Processing
- Data Entry Requests
- Registration Objects
- Submission Objects
- Regulatory Events
- Submission Creation
- Regulatory Data Maintenance
- Data Quality Checks
- Data Reconciliation
- Health Authority Correspondence
- Global Regulatory Submissions
- xEVMPD
- IDMP
- SPOR
- Product Detail Set
- Renewals
- Variations
- Approvals
- Transfers
- Withdrawals
- eCTD
- Regulatory Data Governance
- Regulatory Analytics
- PMS
- CAPA Analysis