•Develop and manage audit database system to monitor responses, schedules and observations for 45 Plasmapheresis facilities.•Assist with the development and review of audit responses.•Facilitate and monitor all internal/external audit response activity through final completion/approval.•Direct interface with Regulatory agencies such as FDA, Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA), State and Health Departments.•Oversee facility certifications, permits, registrations and licenses.•Prepare applications and correspondence for Regulatory agencies.•Generate and distribute audit status/regulatory reports.

• Interface with Regulatory Agencies such as FDA, Commission on Office Laboratory Accreditation (COLA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA), State and Health Departments.• Prepare and assist with the completion of regulatory documentation: FDA Biologics License Applications (BLA), FDA Pre-License Inspection Requests, European Authority Site Master Files, FDA submissions (such as product label, computer system, testing and laboratory changes and FDA Annual Reports), and inspection response templates for FDA 483 findings and online registrations.• Participant in CBER’s eSubmitter Pilot Evaluation Program. Identified an issue with the software that prevented the successful completion of the electronic submission. Provided constructive feedback to FDA which resulted in a correction to the program prior to the process being made available to industry.• Develop and maintain quality system databases to monitor and track Regulatory / Quality timelines and expirations such as Physician Substitute/Physician licenses & CPR certificates, plasma center CLIA Registrations, PPTA Certifications and State Licenses, CAPAs, and internal / external audits.• Participate as needed in internal, customer and other external inspections such as EU, COLA, FDA, PPTA.• Provide Regulatory support for 24 Plasmapheresis centers.• Re-create plasma center floor plans in Visio for Customer and European inspections.• Supervise the Regulatory Affairs / Quality Assurance Department Administrative staff to ensure proper support of the department. Act as coach and mentor to others in regards to Regulatory functions.

• Assisted with the development of FDA submissions: 510(k)s, INDs, IDEs, NDAs, annual reports, product registrations, supplements and responses.• Identified and collected information critical to submission packages.• Performed quality control of content and monitored progress of pending submissions.• Prepared Principle Investigator Packages and maintained contracts of study sites.• Ensured that all documents critical to clinical trials were obtained and kept on file.• Reorganized, managed / maintained Document Control system for Medical Device/Pharmaceutical Client.