Art Faulkner
Vice President, Regulatory Cmc @TG Therapeutics, Inc.
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WORK HISTORY
Vice President, Regulatory Cmc @TG Therapeutics, Inc.
Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, DMFs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submissions and marketing applications to the FDA, and if required international regulatory authorities), and ensure appropriate follow-up correspondence. • Leads the hands-on preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, quality, process improvement and laboratory control. • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities. • Provide timely responses to CMC questions from regulatory authorities. • Serves as interface with reviewers from FDA and other health authorities. • Provides regulatory CMC expertise during due diligence and in support of new projects. • Coordinates activities for meetings with FDA and other regulatory authorities, and leads negotiations and interactions with regulatory authorities. • Interprets and communicates regulatory expectations to internal and external stakeholders to execute program objectives. • Maintains current knowledge of regulations and guidelines (FDA, ICH and other as required). • Ensures compliance with health authority regulations. • Define global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance. • Reviews clinical study protocols, clinical study reports, investigator brochures and CMC reports. • Interprets pre-clinical and clinical results and develop those into sound regulatory positions and strategy. • Communicates CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to project team and appropriate management levels.
EDUCATION
Rutgers University
Chemistry
University of Scranton
Bachelor's degree, Biology, General
Bucknell University
Master's degree, Analytical Chemistry
SKILLS
ABOUT ART FAULKNER
An accomplished Regulatory Chemistry, Manufacturing and Controls (CMC) professional with…
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