Business Analyst - Regulatory​/RIM SME

Location:

Richmond, VA – Remote with onsite workshops as needed

Employment Type:

Contract, W2 only through HTD Talent

Duration: 8 months

Schedule:

40 hours/week

Position Summary:

Seeking a Regulatory Affairs SME / Business Analyst to support a digital transformation project implementing a Regulatory Information Management (RIM) system. This business-focused role will gather requirements, develop process flows, and collaborate with stakeholders to support RIM deployment. Responsibilities do not include preparing FDA or other agency submissions.

Responsibilities:

• Gather and document business requirements.

• Create and update business process flows.

• Prepare business requirements and supporting RIM documentation.

• Collaborate with business stakeholders throughout implementation.

• Attend client workshops and onsite activities in Richmond as needed.

Required Qualifications:

• 10+ years of regulatory affairs experience.

• Regulatory Information Management (RIM) experience required.

• 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 Word, Excel, PowerPoint, and Visio.

Preferred Qualifications:

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

• Pharmaceutical or medical device regulatory experience accepted with willingness to learn tobacco regulations.

Travel / Onsite:

Must be available for client workshops and onsite work in Richmond, VA, as needed. Driving proximity is preferred. Client will reimburse hotel expenses when applicable.