Business Analyst – Regulatory Affairs​/RIM

Hybrid/Richmond, VA
- Full
- Time

Are you a Regulatory Affairs Business Analyst who can translate complex regulatory and business needs into clear requirements, process flows, and system-ready documentation? This role is ideal for someone with deep Regulatory Affairs experience who enjoys partnering across business and technology teams to help drive a successful Regulatory Information Management (RIM) implementation.

The Business Analyst
- Regulatory Affairs / RIM will support the business side of a Regulatory Information Management system implementation, serving as a bridge between Regulatory Affairs stakeholders and the teams responsible for delivering the solution.

In this role, you’ll gather and document business requirements, develop current- and future-state process flows, facilitate stakeholder discussions, and translate regulatory processes into clear, actionable requirements for the RIM implementation.

This is not a regulatory submissions production role
. Rather than compiling or submitting documents directly to the FDA or other Health Authorities, you’ll use your Regulatory Affairs expertise to help business and technology teams understand regulatory workflows, requirements, and documentation needs so the RIM solution effectively supports the business.

As Business Analyst – Regulatory Affairs / RIM, you will:

• Lead or support the business in gathering, organizing, and documenting requirements for a RIM system deployment.
• Create, update, and maintain process flows that reflect Regulatory Affairs business processes and system needs.
• Collaborate with Regulatory Affairs stakeholders, business users, technology teams, and implementation partners to clarify requirements and priorities.
• Support stakeholder discussions, workshops, and working sessions to understand current-state and future-state processes.
• Translate regulatory business needs into clear business requirements, process documentation, and system-supporting materials.
• Apply Regulatory Affairs subject matter expertise to help teams understand Health Authority regulations, regulatory workflows, and RIM-related needs.
• Support documentation related to regulatory submissions processes, annual reports, Health Authority conversations, and related regulatory activities as they connect to the RIM system.
• Help compile and organize documents needed to support a RIM system implementation, including business requirements and related process materials.
• Use tools such as Word, Excel, PowerPoint, and Visio to document requirements, process flows, stakeholder inputs, and project materials.
• Partner with cross-functional teams to ensure business requirements are understood, traceable, and aligned to implementation goals.

You will likely be successful in this role if you have:

• 10+ years of Regulatory Affairs experience, with direct experience working in regulatory affairs required.
• Regulatory Information Management experience required.
• Experience supporting or working with RIM systems, RIM processes, or RIM system deployments.
• Experience with Health Authority regulations, ideally FDA regulations applicable to the tobacco industry.
• Experience with Health Authority regulations in pharma or medical device environments, with willingness to learn tobacco regulations, may also be considered.
• Experience with regulatory submissions processes, including annual reports and Health Authority communications or conversations.
• Strong stakeholder management experience, including the ability to work with business users, regulatory teams, technical teams, and project stakeholders.
• Experience gathering requirements, documenting business needs, and supporting process documentation…