RIM-Powered Regulatory Affairs Analyst

FormativGroup, LLC; Washington, Baltimore (District of Columbia, MD); Híbrido; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

FormativGroup is seeking a Business Analyst - Regulatory Affairs / RIM to bridge Regulatory Affairs with IT during a RIM system implementation. You will gather requirements, map processes, and translate regulatory needs into actionable specifications for the project team.

This hybrid role near Richmond, VA, emphasizes stakeholder facilitation and document-driven collaboration across regulatory, business, and technology groups. A strong background in health authority regulations is essential.

Formación

• 5+ years of direct Regulatory Affairs experience.
• Experience with Regulatory Information Management (RIM) systems or processes.
• Knowledge of Health Authority regulations and regulatory workflows in pharma, medical device, or tobacco environments.
• Understanding of regulatory submissions, annual reporting, and Health Authority communications.
• Strong stakeholder management across regulatory, business, and technology teams.

Responsabilidades

• Gather, organize, and document business requirements for a RIM system implementation.
• Develop current- and future-state process flows for Regulatory Affairs processes and system needs.
• Facilitate discussions with Regulatory Affairs stakeholders, business users, technology teams, and implementation partners.
• Translate regulatory workflows and business needs into clear, actionable system requirements and supporting documentation.
• Apply Regulatory Affairs knowledge to help teams understand Health Authority requirements.
• Support documentation related to regulatory submissions processes, annual reports, Health Authority interactions, and other activities connected to the RIM system.
• Ensure requirements and process documentation are clear, traceable, and aligned with implementation goals.
• Use Word, Excel, PowerPoint, and Visio to develop requirements, process flows, and project materials.

Conocimientos

Regulatory Affairs

RIM systems

Stakeholder management

Process mapping

Regulatory workflows

Herramientas

Word

Excel

PowerPoint

Visio

Descripción del empleo

FormativGroup is seeking a Business Analyst - Regulatory Affairs / RIM to bridge Regulatory Affairs with IT during a RIM system implementation. You will gather requirements, map processes, and translate regulatory needs into actionable specifications for the project team.

This hybrid role near Richmond, VA, emphasizes stakeholder facilitation and document-driven collaboration across regulatory, business, and technology groups. A strong background in health authority regulations is essential.