Is this youAre you a Regulatory Affairs Business Analyst who understands how to translate business needs into clear requirements, process flows, and system-ready documentation? This role is a great fit for someone who brings deep regulatory experience and enjoys working with stakeholders to support the successful deployment of a Regulatory Information Management system.
About the roleThe Business Analyst - Regulatory Affairs / RIM role is focused on supporting the business-side deployment of a Regulatory Information Management system.
This role sits at the intersection of Regulatory Affairs, business process, stakeholder collaboration, and system implementation support.As Business Analyst - Regulatory Affairs / RIM, you will help gather and organize requirements, create and update process flows, support stakeholder conversations, and document business needs for a RIM system deployment.This role is not focused on compiling regulatory submissions to the FDA or any other agency; it is focused on helping business and technology teams understand regulatory processes, requirements, and documentation needs that support a successful RIM implementation.
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.
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.
- 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
We are committed to pay equity and transparency. The compensation range for this position represents our good faith estimate of the range we reasonably expect to pay for this role at the time of posting. The actual compensation offered will be determined based on factors such as the candidate's experience, skills, education, work location, and internal equity.
In addition to base pay, employees may be eligible for discretionary bonuses, commissions, or other incentive programs, as well as a comprehensive benefits package that includes medical, dental, vision, 401(k), paid time off, etc.
Estimated Compensation Range:
$85-$95 USD
