Christophe Tetar

WORK HISTORY

EDUCATION

SKILLS

ABOUT CHRISTOPHE TETAR

My Responsibilities:• Ensure all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance.• Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA), European Union, Latin America, Canada and Asia Pacific regulations/interpretations. This may include the review, evaluation, and compilation of files and reports for submissions.• Provide project team representation and direction in managing information from/to other departments (including Product Development, Manufacturing, Quality, Marketing, and Clinical Affairs) regarding Regulatory submissions. This may included the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.• Review technical and clinical documentation and recommend changes for labeling, manufacturing, and clinical protocol for regulatory compliance.• Research and analyze regulatory information and determine acceptability of data, procedures, and other product-related documentation presented in support of product registration.• Responsible for the timely completion of regulatory projects and submission of documentation, both internal and external.• Develop and maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes.• Provide regulatory guidance to project teams.