Business Analyst – Regulatory/RIM SME
htd talentHenrico, VA
Business Analyst – Regulatory/RIM SME
htd talentHenrico, VALead L6
Other Management Consulting ServicesOther Scientific and Technical Consulting ServicesAdministrative Management and General Management Consulting Services
APPLY NOWLocation: 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.
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Level
Lead L6
Location
Henrico, VA
Occupation
Regulatory Affairs Specialists
Industry
Other Management Consulting Services
Posted
4 days ago