Senior Regulatory Operations Specialist - Mesa Arizona

Company: VirtualVocations
Location: Mesa, Arizona
Posted On: 02/06/2025

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 More...

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