Fda Regulatory Attorney in Denver, CO| LawFirmStaff

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Title : Fda Regulatory Attorney

Location : Colorado - Denver
Refer to Job # XVRJ800704


FDA Regulatory Attorney Responsibilities: Provide legal advice and guidance on compliance with FDA regulations related to advertising and promotion, product claims, labeling, manufacturing,and sale and distribution of hemp and marijuana products. Provide strategic counseling and skillful advocacy to companies, subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, FTC and related federal and state laws specific to cannabis products. Manage client interactions with federal and state regulators who oversee product development, manufacturing, and marketing activities. Work with clients to develop pre-market strategies and their implementation, including product development, clinical investigations, expedited review and approval pathways, orphan drug and other designations, premarket applications, dispute resolution and appeals, label negotiations, commercial launch preparation, and inspection readiness. Work with clients to advise on best practices and legal considerations for early-stage food, drug, cosmetic, and dietary supplement products. Act as a liaison with government regulatory bodies and administrative agencies on behalf of clients regarding product issues, inspections, and inquiries. Answer complex compliance questions incorporating nuanced areas of state, local, and federal law and provide insight on enforcement and policy trends. Review packaging, labeling, and marketing materials for compliance. Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions. Supervise associates in FDA, FTC, and regulatory compliance work. Draft, negotiate, and provide guidance related to regulatory requirements relating to commercial agreements, including third-party research, contract manufacturers and suppliers, and sales and distribution. Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions. Qualifications: Juris Doctorate required. Licensed attorney in practicing state(s) required. Minimum of 3 years A? experience in FDA regulatory and compliance representing food, drug and/or device clients or commensurate experience working at the FDA preferred. Food and beverage law expertise preferred. Comprehension of FFDCA and FTC, with experience in quality assurance and GMP preferred. Comprehension of regulations relating to cosmetics, OTC products, and/or consumer products including U.S. Customs and Border Protection and Food & Drug Administration Import Operations preferred. Public-policy and advocacy experience relating to FDA-regulated products preferred. Experience advising clients on labeling, advertising and promotion, adverse event reporting, product recalls, good manufacturing practices (GMPs), agency inspections and remediation of inspection findings as well as responding to agency enforcement actions. Passion for providing unparalleled client service. Experience with Microsoft Office Suite, Adobe Acrobat, NetDocuments,Lexis/Nexis, Westlaw, DocuSign and Clio preferred. Exceptional organization skills, strong self-motivator with high attention to detail. Excellent time and deadline management skills in fast paced environment, ability to juggle multiple projects and reprioritize quickly and efficiently. Excellent oral and written communication skills.
 
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