Business Analyst – Regulatory Affairs / RIM

Is this you?

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.

About the role

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.

What You'll Work On
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.

What You'll Bring
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 for system implementation work.
• Know-how of compiling documents for a RIM system, including business requirements and related implementation materials.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Visio.

How You Work

• You are business-focused, practical, and able to translate regulatory knowledge into clear requirements and process documentation.
• You are comfortable working with multiple stakeholders, asking thoughtful questions, and clarifying details in a structured way.
• You bring strong attention to detail, clear communication, and a collaborative mindset to implementation work that requires accuracy, alignment, and follow-through.

Bonus Points If You Have

• Experience with tobacco regulatory requirements or FDA regulations applicable to tobacco products.
• Experience supporting RIM system implementation, deployment, migration, or optimization projects.
• Experience documenting current-state and future-state regulatory processes.
• Experience working in pharma, medical device, tobacco, or other highly regulated product environments.
• Experience using business process modeling tools beyond Visio.

What Success Looks Like

• Regulatory Affairs requirements are clearly gathered, documented, and aligned to the RIM system deployment.
• Process flows and business documentation accurately reflect stakeholder needs and regulatory workflows.
• Business, regulatory, and technology teams have a shared understanding of requirements, priorities, and implementation expectations.
• Stakeholders view you as a trusted Regulatory Affairs SME who can bridge business needs and system implementation work.
• Your work helps support a smoother, more organized, and business-aligned RIM deployment.

Why Join FormativGroup
FormativGroup is a PE-backed technology consulting and implementation partner helping organizations modernize complex business platforms, improve delivery outcomes, and scale technology solutions that support long-term growth. We partner with clients across strategy, solution design, implementation, and ongoing support to help move critical initiatives from vision to execution. Our teams bring deep technical expertise, delivery discipline, and a collaborative approach to every engagement.

At FormativGroup, you'll work with people who are practical, collaborative, and focused on solving meaningful business and technology problems. We're growing, which means you'll have opportunities to contribute ideas, work closely with experienced leaders, and help shape how we deliver for clients.

Employment Eligibility

• This role is Hybrid, must reside near to Richmond, VA - Not open to travel - must go onsite 1st week and intermittently

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa now or in the future