Business Analyst Regulatory Affai

UsefulBI Corporation is seeking a Regulatory Affairs Business Analyst who will bridge the gap between regulatory compliance and technology. The role focuses on translating complex FDA and global regulatory requirements into clear IT system specifications and optimizing Regulatory Information Management and Electronic Document Management Systems for seamless global electronic submissions.

Responsibilities:

• Requirement Gathering: Interview regulatory teams to capture, analyze, and document business, functional, and technical requirements
• System Optimization: Maintain and configure RIM and EDMS platforms to align with evolving regulatory standards like eCTD and IDMP
• System Validation: Author validation deliverables, including User Requirement Specifications (URS) and test scripts, ensuring compliance with 21 CFR Part 11 and GxP
• Data & Process Mapping: Conduct data gap analyses, map metadata, and design workflows to improve submission tracking and publishing efficiency
• Cross-functional Liaison: Serve as the primary technical point of contact between Regulatory Affairs, Quality Assurance, and IT teams
• Change Management: Draft user guides, create training materials, and support end-users during system upgrades or rollouts

Requirements:

• Bachelor's degree in Life Sciences, Bio-informatics, Computer Science, or a related field
• 3–5 years of business analysis experience within the pharmaceutical, biotech, or medical device industries
• Hands-on experience with Veeva Vault (RIM/Submissions/Docs), OpenText Documentum, or similar life science platforms
• Deep understanding of the drug development lifecycle, health authority guidelines (FDA, EMA), and eCTD publishing workflows
• Proficiency in SQL, MS Visio, Excel, and Agile project tracking tools like Jira and Confluence