RIM-Focused Regulatory Affairs Analyst

FormativGroup, LLC; Richmond (VA); Hybrid; USD 117,000 - 131,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid time off

Job summary

FormativGroup in Richmond, VA is seeking a Business Analyst - Regulatory Affairs / RIM to bridge Regulatory Affairs stakeholders and the RIM implementation team. You will gather requirements, map current and future processes, and translate regulatory needs into clear, actionable specifications.

The role emphasizes deep regulatory know-how, cross-functional collaboration, and practical documentation using Word, Excel, PowerPoint, and Visio, with hybrid work and no travel.

Qualifications

• 10+ years of Regulatory Affairs experience.
• Regulatory Information Management experience required.
• Experience with or supporting RIM systems or deployments.
• Familiarity with Health Authority regulations (FDA) relevant to tobacco/pharma/devices.
• Experience gathering requirements and documenting business needs.
• Proficiency with Word, Excel, PowerPoint and Visio.

Responsibilities

• Lead or support gathering, organizing, and documenting requirements for a RIM deployment.
• Create, update, and maintain process flows reflecting Regulatory Affairs processes.
• Collaborate with stakeholders, business users, technology teams, and partners to clarify requirements.
• Facilitate stakeholder discussions, workshops, and sessions on current and future state processes.
• Translate regulatory needs into clear business requirements and system materials.
• Apply regulatory expertise to explain health regulations and RIM-related needs to teams.
• Support documentation for regulatory submissions processes and ongoing regulatory activities.
• Compile documents to support RIM implementation, including business requirements and process materials.
• Document requirements and materials using Word, Excel, PowerPoint, and Visio.
• Partner with cross-functional teams to keep requirements traceable and aligned with goals.

Skills

Regulatory affairs

RIM systems

Stakeholder management

Requirements gathering

Process documentation

Regulatory workflows

Health Authority regs

Cross-functional collaboration

Documentation clarity

Regulatory submissions support

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Visio

Job description

FormativGroup in Richmond, VA is seeking a Business Analyst - Regulatory Affairs / RIM to bridge Regulatory Affairs stakeholders and the RIM implementation team. You will gather requirements, map current and future processes, and translate regulatory needs into clear, actionable specifications.

The role emphasizes deep regulatory know-how, cross-functional collaboration, and practical documentation using Word, Excel, PowerPoint, and Visio, with hybrid work and no travel.