Business Analyst - Regulatory Affairs/RIM
Core
Lead or support the gathering, organization, and documentation of business requirements for a Regulatory Information Management (RIM) system deployment.
Role type
Senior Business Analyst (Regulatory Affairs/RIM)
Builds
RIM system implementation documentation and process flows
Domain
Healthcare Regulatory Affairs / Health Authority Compliance
Required skills
Regulatory Information Management (RIM) systems, Health Authority regulations, regulatory submissions processes, business requirements gathering, process documentation, Microsoft Visio, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, stakeholder management, business process modeling
Preferred skills
FDA tobacco regulations, RIM implementation/deployment/migration/optimization, documenting current- and future-state processes, business process modeling tools beyond Visio, highly regulated industries experience
Technologies
Excel, Visio, Word, PowerPoint
Responsibilities
Lead or support the gathering, organization, and documentation of business requirements for a RIM system deployment. Create, update, and maintain process flows that represent Regulatory Affairs processes and system needs. Work with Regulatory Affairs stakeholders, business users, technology teams, and implementation partners to clarify requirements and priorities. Facilitate stakeholder discussions, workshops, and working sessions to understand current- and future-state processes. Translate regulatory business needs and workflows into actionable requirements, process documentation, and system-supporting materials. Support documentation for regulatory submissions processes, annual reports, Health Authority conversations, and related activities as they connect to the RIM system.
Seniority
Senior, hands-on IC