• Design and implement regulatory compliance strategies for projects related to manufacturing, labeling, and clinical research• Prepare accurate and complete domestic and international regulatory submissions, and submit on time• Review process and product changes, labeling, marketing literature and clinical protocols, to determine the need for regulatory submissions and compliance to FDA and international requirements• Serve as liaison for FDA and other regulatory agencies• Conduct GMP training to the organization• Mentor less experienced staff members in preparing submissions• Provide guidance to all levels of the organization regarding compliance with FDA requirements and international standards• Review and approve investigations, complaints, MDR, SOPs, design control and validation data • Possess strong analytical and communication skills

Design and implement regulatory compliance strategies for projects related to manufacturing, labeling, and clinical researchPrepare accurate and complete domestic and international regulatory submissions, and submit on timeReview process and product changes, labeling, marketing literature and clinical protocols, to determine the need for regulatory submissions and compliance to FDA and international requirements Filed approximately 510 (k),traditional and special; approvals received without major deficiencies Filed BLA, PAS, CBE-30, CBE; approvals received without major deficiencies.Filed Health Canada Class III/IV licenses, fax back license updates. Serve as liaison for FDA and other regulatory agencies Responsible for GMP training and communicating recent industry developments to the organization Serve as FDA Inspection CoordinatorManage Adverse Event reporting program; first in the industry to file eMDRs to CDRH Mentor less experienced staff members in preparing submissions and filing MDRs Provide guidance to all levels of the organization regarding compliance with FDA requirements and international standards Review and approve investigations, complaints, SOPs, validation and research data Possess strong analytical and communication skills

• Design and implement regulatory compliance strategies related to process and product changes• Provide guidance to all levels of the organization regarding compliance with FDA requirements and international standards• Perform pre-FDA inspection audits • Implement FDA remediation strategies • Serve as FDA Inspection Coordinator at multiple sites• Lead internal audit teams and serve as a liaison for consultant activities• Display excellent communication skills as a presenter on GMP compliance trends, internally, to the organization, and externally at key industry conferences • Review and approve investigations, SOPs, validation and research data • Member of Parenteral Drug Association (PDA); served on FDA Inspections Task Force

•Organize, conduct and lead GMP audits at Pharmaceutical, Veterinary Pharmaceuticals, Biologics and Medical Device Manufacturing facilities•Recognized as district drug inspection expert •Organize teams and assign project responsibility •Key member of a task force that streamlined standard operating procedures and official guidance documents related to critical program areas (e.g. Pre-Approval Inspections, API) •Interim assignments as CDER Compliance Officer, District Pre-Approval Manager, Recall Coordinator, and Public Affairs Specialist•Earned recognition for significant contributions to the agency, including Commissioner’s Group Recognition Award•Experience in organizing events and coordinating departmental teams •Present GMP training and inspection trends at key industry conferences•Prepare and present staff orientation package to pharmaceutical inspectors•Member of International Inspection Cadre•Independent coursework in Pharmacology, Pharmacy, Epidemiology