Business Analyst – Regulatory Affairs / RIM

FormativGroup•Richmond, VA

2d•Hybrid

About The Position

The 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.

Requirements

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 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.

Nice To Haves

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.
Experience with Health Authority regulations in pharma or medical device environments, with willingness to learn tobacco regulations, may also be considered.

Responsibilities

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.