Senior Regulatory Operations Specialist
Company: VirtualVocations
Location: Detroit
Posted on: January 28, 2025
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Job Description:
A company is looking for a Senior Reg Ops Specialist SME to
support the Biomedical Advanced Research and Development Authority
(BARDA).
Key Responsibilities
Provide subject matter expertise in chemical, radiological, and
biological threats, including the development and regulatory
approval of medical countermeasures
Review and assess technical proposals, study protocols, and
regulatory documents, offering expert recommendations and
guidance
Coordinate with federal staff and project managers on submission
timelines and regulatory requirements, ensuring compliance with FDA
standards
Required Qualifications
Bachelor's degree or equivalent experience
Minimum of 15 years of experience in regulatory operations
supporting drug, biologic, and device development
Expert knowledge of FDA submission types and eCTD
specifications
Experience with electronic publishing software and advanced PDF
processing tools
Ability to obtain a public trust clearance; U.S. citizenship
required
Keywords: VirtualVocations, Detroit , Senior Regulatory Operations Specialist, Other , Detroit, Michigan
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