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ProfileMiami office of our client seeks FDA associate attorney with 5+ years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct legal research, analyze data, draft evidence-based opinions and provide oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Manage FDA-related legal matters independently with minimal supervision including: Advise clients and manage with minimal supervision legal and regulatory matters involving food, food ingredients, the generally recognized as safe (GRAS) notification process, dietary supplements, dietary ingredients, new dietary ingredient (NDI) notifications, food and dietary supplement good manufacturing practices (GMP) regulations recall management and assistance, FDA 483 and Warning Letter response, case management and representation (multiple industries), product labeling reviews; product website and marketing reviews, importation, exportation and supply management of FDA-regulated products; and similar FDA-related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of FDA-regulated products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining an appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies? regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under FDA, USDA, Customs and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Must be licensed to practice law in any state and/or the District of Columbia. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required. Prior work experience with FDA and/or other government agencies preferred. Spanish, Mandarin, Cantonese or Korean language capabilities is preferred.
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