About this opportunity
HTD Talent lists this Business Analyst - Regulatory/RIM SME opportunity in richmond, va, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.