Business Analyst

About the Role
The Regulatory Affairs Subject Matter Expert (SME) / Business Analyst will support a digital transformation project focused on implementing a Regulatory Information Management (RIM) system. This business-focused role involves gathering requirements, documenting business processes, preparing supporting RIM documentation, and collaborating with stakeholders throughout implementation.
The position requires extensive regulatory affairs experience and familiarity with regulatory submissions, annual reports, and health authority interactions. Responsibilities focus on business requirements and process documentation rather than preparing submissions to the FDA or other regulatory agencies.
Key Responsibilities
Gather, analyze, and document business requirements for the RIM implementation project.
Create and update business process flows to support system deployment.
Prepare business requirements and supporting Regulatory Information Management documentation.
Collaborate with business stakeholders throughout the implementation process.
Participate in client workshops and onsite activities in Richmond, Virginia, as needed.
Support communication and coordination between stakeholders to ensure business requirements and processes are clearly documented.
Required Qualifications
At least 10 years of regulatory affairs experience.
Experience with Regulatory Information Management (RIM) systems.
Experience with regulatory submissions, annual reports, and interactions with health authorities.
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 affairs experience, with a willingness to learn tobacco-specific regulations.
Location & Work Arrangement
Location: Richmond, Virginia.
Work arrangement: Remote, with onsite client workshops and activities in Richmond as needed.
Schedule: 40 hours per week.
Contract duration: 8 months.
Employment type: W-2 contract through HTD Talent.
Travel requirements: Availability for onsite work and client workshops is required. Proximity within driving distance is preferred. Hotel expenses will be reimbursed by the client when applicable.

Work arrangement
Yes