Business Analyst – Regulatory Affairs / RIM

Description

The company is a private equity-backed technology consulting and implementation partner. It helps organizations modernize complex business platforms, improve delivery, and scale technology that supports long-term growth. Its work spans strategy, solution design, implementation, and ongoing support, and it focuses on the middle market, connecting applications and systems to business processes.

This role supports the business side of a Regulatory Information Management (RIM) system implementation. You will be the link between Regulatory Affairs stakeholders and the teams building the solution, so the system fits how regulatory work actually runs.

You will not compile or submit documents to the FDA or other Health Authorities. Instead, you will use your regulatory expertise to help business and technology teams understand regulatory workflows, requirements, and documentation needs.

The goal is requirements and process documentation that are clear, traceable, and aligned to implementation goals, so that business, regulatory, and technology teams share one understanding of what is needed and when.

Responsibilities

• Lead or assist the business in collecting, organizing, and writing down requirements for a RIM deployment.
• Build and keep up to date current-state and future-state process flows that show Regulatory Affairs processes and their system needs.
• Work with Regulatory Affairs staff, business users, technology teams, and implementation partners to settle requirements and priorities.
• Run or join stakeholder discussions, workshops, and working sessions to map how processes work today and how they should work.
• Turn regulatory business needs into clear business requirements, process documents, and materials that support the system.
• Use your Regulatory Affairs knowledge to explain Health Authority rules, regulatory workflows, and RIM needs to the teams involved.
• Support documentation on regulatory submission processes, annual reports, and Health Authority interactions where they connect to the RIM system.
• Help assemble and organize the documents a RIM implementation needs, including business requirements and related process material.
• Use Word, Excel, PowerPoint, and Visio to document requirements, process flows, stakeholder input, and project materials.
• Work with cross-functional teams so that business requirements are understood, traceable, and matched to implementation goals.

Requirements

• 10+ years of Regulatory Affairs experience, including hands-on regulatory affairs work.
• Regulatory Information Management experience.
• Experience with RIM systems, RIM processes, or RIM deployments.
• Experience with Health Authority regulations, ideally FDA regulations that apply to tobacco products.
• Experience with Health Authority regulations in pharma or medical device settings. Willingness to learn tobacco regulations may also be considered.
• Experience with regulatory submission processes, including annual reports and communications or conversations with Health Authorities.
• Strong stakeholder management, including working with business users, regulatory staff, technical teams, and project stakeholders.
• Experience gathering requirements, documenting business needs, and writing process documentation for system implementations.
• Working knowledge of compiling documents for a RIM system, including business requirements and related implementation materials.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Visio.
• You are business-focused and practical, and you can turn regulatory knowledge into clear requirements and process documents.
• You are comfortable working with many stakeholders, ask good questions, and clarify details in a structured way.
• You pay close attention to detail, communicate clearly, and collaborate well on work that demands accuracy, alignment, and follow-through.
• Bonus: Experience with tobacco regulatory requirements or FDA regulations for tobacco products.
• Bonus: Experience supporting RIM implementation, deployment, migration, or optimization projects.
• Bonus: Experience documenting current-state and future-state regulatory processes.
• Bonus: Experience in pharma, medical device, tobacco, or other highly regulated product environments.
• Bonus: Experience with business process modeling tools other than Visio.

Conditions

This role is hybrid. You must live near Richmond, VA, and go onsite during the first week and at times after that. Travel is not open for this role.

You must be authorized to work for any employer in the U.S. The company cannot sponsor an employment visa now or in the future, nor take over an existing sponsorship.

The estimated hourly pay range is $85-$95 USD. Final pay depends on experience, skills, education, work location, and internal equity.

Reasonable accommodations are available for individuals with disabilities to perform the essential functions of the role.

Benefits

• Possible eligibility for discretionary bonuses, commissions, or other incentive programs, in addition to hourly pay.
• Comprehensive benefits including medical, dental, vision, 401(k), paid time off, and more.
• You will work with practical, collaborative people, and the company is growing, so there is room to share ideas, learn from experienced leaders, and help shape how it delivers for clients.