Business Analyst - Regulatory/RIM SME

Job Description

Location: Richmond, VA – Remote with onsite workshops as needed

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Employment Type: Contract, W2 only through HTD Talent

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Duration: 8 months

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Schedule: 40 hours/week

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Position Summary:

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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.

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Responsibilities:

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• Gather and document business requirements.

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• Create and update business process flows.

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• Prepare business requirements and supporting RIM documentation.

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• Collaborate with business stakeholders throughout implementation.

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

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Required Qualifications:

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• 10+ years of regulatory affairs experience.

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• Regulatory Information Management (RIM) experience required.

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

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• Strong stakeholder engagement and management skills.

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• Experience preparing business requirements and process documentation.

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

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Preferred Qualifications:

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

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

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Travel / Onsite:

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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.

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