Associate - Biologics Consulting Group, Inc
Alexandria, VA.

• Serves as a project manager for FDA submissions
  • Including INDs, BLAs and ODDs
  • 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
• Provides regular support to US Agent clients with regard to IND and BLA maintenance

• Responsible for all regulatory activities in the Americas for Australian-based bio-pharmaceutical company.
  • Planned and prepared regulatory submissions and documents
  • Drafted and edited protocols and final reports
  • Researched and wrote scientific literature reviews
  • Created standard operating procedures for key regulatory and clinical functions
  • Ensured data quality and integrity
  • Participated in a due diligence preclinical review.
• Managed all aspects of research development projects.
  • Directly involved with product development strategies and planning.
  • Coordinated the design, initiation and completion of preclinical and clinical studies.
  • Worked with a wide range of professionals including manufacturing, marketing and business development personnel, independent consultants, clinical research organizations, principal investigators, scientific review committees and peer review boards.
  • Budgeted and executed service agreements with selected principal investigators, academic institutions and contract research laboratories.
• Researched Latin American regulatory requirements and processes, and potential commercial partners for business development evaluation.
• Presented research and program updates to upper management, consultants, investigators and international commercial partners on a frequent basis.

• Wrote and prepared protocol and information amendments, safety reports and annual progress reports for Investigational New Drug (IND) applications, Investigational Device Exemptions and Pre-market Approval applications.  Assisted physicians with preparing Sponsor-Investigator INDs.
• Worked with microbiologists and manufacturing personnel in formulating responses to regulator inquiries.
• Supervised and coordinated the labeling and packaging of investigational drug supplies.

• Provided regulatory advisement to the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and related contractors for the initiation and completion of all NIAID-sponsored clinical trials.
• Supervised four regulatory professionals, conducted quality assurance reviews of all regulatory submissions and assisted with departmental management issues.

• Prepared and submitted regulatory submissions into 14 foreign countries for marketed and/or investigational pharmaceutical products.  Facilitated the regulatory process by liaising with foreign governmental authorities, consultants and all company departments.