Overview
Regulatory Business Analyst Jobs in United States at United Pharma
Title: Regulatory Business Analyst
Company: United Pharma
Location: United States
About the Job:
We are seeking an experienced Regulatory Business Analyst to support Regulatory Information Management (RIM) initiatives within a pharmaceutical environment. The ideal candidate will serve as the Veeva Vault RIM SME, supporting data remediation, regulatory processes, system enhancements, and business operations.
Key Responsibilities:
- Serve as the SME for Veeva Vault RIM configuration, business processes, and data management.
- Support data remediation activities using IDMP data models, including PMS, to ensure accurate regulatory data.
- Collaborate on Veeva Quality to Veeva RIM integrations and regulatory system improvements.
- Support validation activities including UAT coordination, test script review, and SDLC documentation.
- Develop SOPs, training materials, user documentation, and regulatory process documentation
- Monitor Veeva RIM reporting, KPIs, and support digital transformation initiatives including AI/GenAI technologies.
Qualifications:
- Strong experience with Veeva Vault RIM, IDMP, eCTD, and SDLC processes.
- Experience with regulatory data remediation and validation activities.
- Knowledge of Veeva RIM reporting, integrations, and regulatory submissions.
- Experience with eCTD publishing and eCTD 4.0 is a plus.
