Regulatory Information Management (RIM) Operations Manager

MSI Pharma; Town of Belgium (WI); On-site; USD 75,000 - 100,000; Full time

Job summary

MSI Pharma is seeking a Regulatory Operations Manager to support global regulatory teams, ensuring high-quality regulatory data and effective governance. Key responsibilities include providing support for regulatory systems, performing data quality checks, and acting as a liaison with regulatory users. Ideal candidates will have experience with RIM systems, strong knowledge of submissions, and a bachelor’s degree, with a preference for those with life sciences backgrounds. This is a freelance position based in the United States.

Qualifications

• Experience working with Regulatory Information Management (RIM) systems.
• Strong understanding of regulatory data and submissions.
• Familiarity with IDMP and controlled vocabularies.

Responsibilities

• Provide first-line support for global RIM and document management systems.
• Perform data quality checks and remediation within regulatory databases.
• Act as a liaison between regulatory users and governance groups.

Skills

Regulatory Information Management (RIM)

Regulatory data quality

Submission knowledge

Audits knowledge

Attention to detail

Analytical mindset

Effective communication

Education

Bachelor's degree

Degree in life sciences or related discipline

Job description

Location: Brussels,Belgium

EngagementStatus: Freelancepositionuntilendof2026withpossibilityofextension

Overview

Wearepartneringwithalargeglobalpharmaceuticalcompanytosupportregulatoryoperationsacrossadiverseproductportfolio.TheRIMOperationsManagersupportsglobalregulatoryteamsbyensuringhigh‑qualityregulatorydata,effectivesystemusage,andstrongprocessgovernanceacrossregulatoryinformationmanagementplatforms.

Key Responsibilities

• Providefirst‑linesupportandtrainingforglobalRIManddocumentmanagementsystems
• Performdataqualitychecksandremediationwithinregulatorydatabases
• Author,review,andmaintainSOPs,validationdocuments,anduserguides
• SupportHealthAuthoritysubmissions,inspections,audits,andCAPAactivities
• Actasaliaisonbetweenregulatoryusers,dataowners,andgovernancegroups

Requirements

• ExperienceworkingwithRegulatoryInformationManagement(RIM)systems
• Strongunderstandingofregulatorydata,submissions,andlicensetracking
• Knowledgeofaudits,inspections,andregulateddocumentation
• FamiliaritywithIDMP,controlledvocabularies,andmasterdataconcepts

Hard Skills

• ExperiencewithRegulatoryInformationManagement(RIM)systems
• Regulatorydataqualityandgovernanceexpertise
• Knowledgeofsubmissions,licensetracking,andaudits
• UnderstandingofIDMPandcontrolledvocabularies

Soft Skills

• Strongattentiontodetail
• Analyticalandproblem‑solvingmindset
• Abilitytoworkautonomouslyinregulatedenvironments
• Effectivecommunicationwithglobalstakeholders

Education

• Bachelor’sdegreerequired
• Degreeinlifesciencesorarelateddisciplinepreferred