Associate, Biologics Consulting Group Inc.
Alexandria, VA.

• Serves as a project manager for FDA submissions
  • Including INDs and BLAs and RAC submissions to OBA
  • Familiar with FDA policies and procedures at CDER/CBER
  • Has assisted clients with Establishment Registration and Drug Listing
  • Familiar with legacy IND format (following form 1571) and CTD format
  • Can provide document formatting assistance for Word files
  • Readies documents for printing or electronic submission
  1. Provides electronic publishing services for FDA submissions
  • Familiar with publishing and submission of electric documents to FDA
  • Familiar with legacy IND format (following form 1571) and CTD format
  2. Provides regulatory support to US Agent clients with regard to IND and BLA maintenance

• Responsible for lead generation for contract manufacturing of diagnostics
• Maintained database of current clients and potential leads
• Conducted internet research to establish potential leads

• Researched immunochromatographic techniques for drug screening urine tests.
• Prepared reagents according to SOPs
• Evaluated and optimized the test components for rapid diagnostic tests
• Reported and recorded the test results, keeping the records according to FDA's GLP requirements
• Performed in-house drug testing on walk-in patients

CONTINUING EDUCATION:

PROFESSIONAL SOCIETIES

• Regulatory Affairs Professional Society (RAPS) - member 2001 to present

HONORS AND AWARDS

2009                BCG special appreciation peer award for electronic submission work

Page Updated: November 5, 2009