Regulatory Affairs Business Analyst - RIM

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.

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.

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.

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.

• 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.

• 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.

• 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.

Formativ Group is a PE-backed technology consulting and implementation partner helping organizations modernize complex business platforms, improve delivery outcomes, and scale technology…