Regulatory Affairs Administrative Assistant

A company is looking for an Administrative Assistant - Regulatory Affairs to maintain regulatory documentation for investigational drug studies. Key Responsibilities Maintain the Investigator Site File (ISF) for assigned studies, including IRB submissions and approvals Manage documentation and obtain Investigator signatures for study-specific documents Handle monitor visits and manage training documentation for study staff Required Qualifications High school diploma or equivalent Proficient working knowledge of Microsoft Word Strong organizational skills and ability to complete tasks with minimal supervision Detail-oriented with good spelling, composition, and proofreading skills Ability to understand instructions and compose reports and correspondence

Jun 25, 2025 - 11:20

A company is looking for an Administrative Assistant - Regulatory Affairs to maintain regulatory documentation for investigational drug studies. Key Responsibilities Maintain the Investigator Site File (ISF) for assigned studies, including IRB submissions and approvals Manage documentation and obtain Investigator signatures for study-specific documents Handle monitor visits and manage training documentation for study staff Required Qualifications High school diploma or equivalent Proficient working knowledge of Microsoft Word Strong organizational skills and ability to complete tasks with minimal supervision Detail-oriented with good spelling, composition, and proofreading skills Ability to understand instructions and compose reports and correspondence