Business Analyst - RIM

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

Jun 11, 2025 - 02:20

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