Associate Director, Regulatory Affairs
CurrentSuccessfully prosecute registration of New Animal Drug Applications (NADAs) through FDA/CVM.-Have an excellent understanding of the 21 CFR for new animal drug applications, and the ability to interpret regulations and to leverage them into favorable strategies for drug registration and appropriate drug Labeling. - Build and maintain professional relationships with regulatory officials for the purpose of receiving clear guidance on preparation of new animal drug applications.- Lead multi-disciplinary teams in creation of global development programs for new chemical entities and life-cycle extensions. - Provide regulatory leadership across the organization on current CVM policies/procedures.- Prepare teams for discussions with agency, submissions of new animal drug applications and any additional queries.- Provide approved product support as needed.Lead Labeling & Drug Experience Regulatory Team.- Team is responsible for submissions of all final printed labels to the agency for review and approval.- Team is responsible for submission of all drug experience reports for FDA regulated products as well as antimicrobial reports.
