Regulatory Information Management- RIM

1. 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

1. 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/recent 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