Business Analyst - RIM

Job Summary

A company is looking for a Business Analyst - RIM.

Key Responsibilities

• Act as a liaison between Regulatory Affairs, CMC, and IT teams to evaluate regulatory systems and define future processes
• Lead initiatives for eCTD 4.0 implementation, focusing on CMC data requirements and document lifecycle management
• Analyze and map regulatory data and workflows, identifying gaps and areas for system and process improvement

Required Qualifications

• 4+ years of experience as a Business Analyst in the biopharma regulatory domain
• Hands-on experience with Veeva Vault RIM or similar regulatory platforms
• Strong understanding of CMC regulatory processes and data requirements
• Familiarity with eCTD format and changes related to eCTD 4.0
• Bachelor's degree in Life Sciences, Information Systems, or a related field