Senior FDA Associate Attorney

Job Title: Senior FDA Regulatory Attorney

Job Overview: A prestigious law firm located in Denver, CO, is seeking a Senior FDA Regulatory Attorney. This role offers a unique opportunity to lead and expand a regulatory compliance practice, specifically within the growing sectors of consumer products, including those containing novel ingredients such as hemp and functional mushrooms. The ideal candidate will provide strategic guidance on compliance with federal and state regulations, particularly relating to the Federal Food, Drug, and Cosmetic Act (FFDCA), and have expertise in food and drug law regulation. The firm is committed to excellence in emerging industries, including dietary supplements, cannabis, and psychedelic products.

Duties:

• Provide legal advice on FDA regulations regarding product claims, labeling, manufacturing, advertising, and distribution of consumer products, including cannabis, hemp, and others.
• Offer strategic guidance on compliance with the Federal Food, Drug, and Cosmetic Act, FTC regulations, and federal/state laws.
• Manage client relations with federal and state regulators overseeing product development, manufacturing, marketing, and alcohol licensing.
• Assist clients with pre-market strategies, such as product development, clinical investigations, and inspection readiness.
• Advise on regulatory matters concerning food, drugs, cosmetics, dietary supplements, and alcohol products.
• Act as a liaison with regulatory bodies concerning product issues, inspections, and inquiries.
• Review and ensure product packaging, labeling, marketing materials, and websites comply with regulatory standards.
• Supervise associates working on FDA, FTC, TTB, and alcohol regulatory compliance projects.
• Draft and negotiate agreements related to regulatory requirements, including research contracts and supply agreements.

Requirements:

• Minimum of 5+ years of experience in FDA regulatory compliance, particularly with food, drug, device, and/or alcohol products.
• Expertise in food and beverage law, as well as alcohol licensing.
• Strong understanding of FFDCA, FTC regulations, and Good Manufacturing Practices (GMPs).
• Experience advising clients on product labeling, advertising, recalls, GMPs, and agency enforcement actions.

Education:

• Juris Doctorate.
• Bar admission in Colorado.

Certifications:

• Active Bar membership in good standing (Colorado preferred).

Skills:

• Strong organizational and project management abilities.
• Excellent written and verbal communication skills.
• Proficiency in legal research tools such as Lexis/Nexis, and Westlaw, and document management software such as Microsoft Office Suite, Adobe Acrobat, NetDocuments, DocuSign, and Clio.

Job Location:

• Denver, CO.

Founded a decade ago, this national cannabis law firm provides legal and policy services to cannabis and hemp businesses, ancillary companies, investors, and governmental bodies. The attorneys have years of extensive experience working with businesses, advocates, and government officials on a wide variety of legal and policy matters and have helped governments shape regulations at the local, state, and national levels. Many members of the team are widely recognized as leaders in cannabis law and policy and frequently appear in national and local media. The firm is ranked by Chambers and Partners in the USA as Nationwide: Cannabis Law, also was included in the 2020 list of Top Cannabis Law Firms compiled by Green Market Report and Cannabis Law Report. The firm provides a supportive and stimulating culture, and opportunities for long-term personal and professional development. The firm's benefits include health insurance, 401 (K), employee equity incentive plan, paid time-off and holidays, fitness membership reimbursement, paid parental leave, employee referral program, and ongoing professional development and coaching.