Business Analyst

About the Company

HTD Talent is the contracting channel for this opportunity, supporting a client undertaking a digital transformation project involving a Regulatory Information Management (RIM) system. Additional company information was not provided.

About the Role

The Regulatory Affairs SME / Business Analyst will support the implementation of a Regulatory Information Management (RIM) system by gathering business requirements, documenting processes, and working closely with stakeholders throughout the deployment.

This is a business-focused position that requires substantial regulatory affairs experience and a strong understanding of RIM systems, regulatory submissions, annual reports, and health authority interactions. The role focuses on requirements gathering, process documentation, and implementation support. It does not involve preparing FDA or other regulatory agency submissions.

The position is primarily remote, with attendance at client workshops and onsite activities in Richmond, Virginia, as needed.

Key Responsibilities

• Gather, analyze, and document business requirements for the RIM implementation project.

• Create and update business process flows to support system implementation and business needs.

• Prepare business requirements documentation and supporting RIM materials.

• Collaborate with business stakeholders throughout the implementation process.

• Participate in client workshops and onsite activities in Richmond, VA, as required.

• Support the RIM deployment through clear process documentation and stakeholder coordination.

Required Qualifications

• 10+ years of experience in regulatory affairs.

• Experience with Regulatory Information Management (RIM) systems.

• Experience with regulatory submissions, annual reports, and health authority interactions.

• Strong stakeholder engagement and management skills.

• Experience preparing business requirements and process documentation.

• Proficiency in Microsoft Word, Excel, PowerPoint, and Visio.

Preferred Qualifications

• Experience with FDA or other health authority regulations applicable to the tobacco industry.

• Pharmaceutical or medical device regulatory experience is also accepted, provided the candidate is willing to learn tobacco regulations.

Salary & Benefits

Compensation details were not provided in the original job description. Hotel expenses will be reimbursed by the client when applicable for onsite work.

Work Arrangement & Travel

• Work location: Remote, with onsite workshops and activities in Richmond, VA, as needed.

• Contract arrangement: W-2 only through HTD Talent.

• Schedule: 40 hours per week for an 8-month contract.

• Travel: Availability for client workshops and onsite work in Richmond is required. Driving proximity to Richmond is preferred.

• Expenses: Hotel expenses will be reimbursed by the client when applicable.