Regulatory Affairs Business Analyst - RIM

FormativGroup, LLC; Washington, Baltimore (District of Columbia, MD); Hybrid; USD 110,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory Affairs

RIM systems

Stakeholder management

Process mapping

Regulatory workflows

Tools

Word

Excel

PowerPoint

Visio

Job description

Are you a Regulatory Affairs professional with a strong business analysis mindset who enjoys making complex processes easier to understand and execute? Do you know how to work across Regulatory Affairs, business, and technology teams to turn regulatory needs into clear requirements and practical solutions?

If you’ve worked with RIM systems or regulatory technology and enjoy being the person who connects the business need to how the system should work, this could be a great fit.

About the role

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

You’ll gather and document business requirements, map current- and future-state processes, facilitate stakeholder discussions, and translate regulatory needs into actionable requirements and documentation.

This is not a regulatory submissions production role. Instead, you’ll use your Regulatory Affairs knowledge 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:

• 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 and working sessions 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 and regulatory processes.
• 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 tools such as Word, Excel, PowerPoint, and Visio to develop requirements, process flows, and project materials.

What You'll Bring

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

• 5+ years of direct Regulatory Affairs experience.
• Experience working with Regulatory Information Management (RIM) systems or processes.
• Experience gathering business requirements, documenting processes, and supporting system implementation initiatives.
• Knowledge of Health Authority regulations and regulatory workflows within pharma, medical device, or tobacco environments.
• Understanding of regulatory submissions processes, annual reporting, and Health Authority communications.
• Strong stakeholder management skills with experience working across regulatory, business, and technology teams.
• Ability to translate complex regulatory processes into clear business requirements and process documentation.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Visio or similar process-mapping tools.

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.
• Hands-on experience supporting a RIM implementation, deployment, migration, or optimization.
• Experience documenting current- and future-state regulatory processes.
• Experience with business process modeling tools beyond Visio.

What Success Looks Like

• Regulatory Affairs requirements and processes are clearly documented and aligned with the RIM implementation.
• Business and technology teams have a shared understanding of regulatory requirements, workflows, and priorities.
• Stakeholders have clear, usable process flows and system requirements to support implementation.
• You become a trusted bridge between Regulatory Affairs and the teams delivering the RIM solution.

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.

• 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.
• To be considered for this position, candidates must reside in one of the following U.S. states: MA, NC, VA, and Washington DC. Candidates residing outside these states are not eligible for consideration currently