Employer Industry: Biotechnology and Pharmaceutical Development

Why consider this job opportunity:
- Competitive salary with comprehensive benefits package
- Opportunity for career advancement and growth within the organization
- Engaging work environment with a focus on mission-driven projects
- Chance to contribute to public health and safety through innovative medical countermeasures
- Support for ongoing education and professional development

What to Expect (Job Responsibilities):
- Provide subject matter expertise in the development of medical countermeasures for various health threats
- Advise on technical evaluation panels and participate in program coordination teams
- Review and comment on regulatory documents and study protocols
- Develop expert analysis reports and other technical documents related to BARDA's mission
- Coordinate and manage eCTD submissions and liaise with regulatory affairs project managers

What is Required (Qualifications):
- Bachelor’s degree or equivalent with recognized expertise in Regulatory Operations
- At least ten (10) years of progressive experience in regulatory operational activities for drug and device development
- Expert knowledge of FDA submission types and eCTD specifications
- Proficient in electronic publishing software and advanced PDF processing tools
- Superior competency in MS Word and experience with Accenture Starting Point

How to Stand Out (Preferred Qualifications):
- Superior competency in Adobe Acrobat and ISIToolbox™ or other PDF toolsets
- Ability to build XML documents using Lorenz or similar publishing software
- Experience with FDA and ICH content requirements for CTD dossiers

#Biotechnology #PharmaceuticalDevelopment #RegulatoryAffairs #CareerOpportunity #PublicHealth

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