Senior Associate Attorney - FDA

Vicente LLP, a top-ranked cannabis and psychedelic law firm, is seeking an FDA regulatory attorney with a portable book of business.

This role offers a unique opportunity to lead and expand a regulatory compliance practice, supporting companies developing and selling consumer products containing novel ingredients such as hemp, functional mushrooms, and others.

The firm is mission-driven and committed to excellence in emerging industries.

We are seeking an attorney with five or more years of experience in food and drug law regulation, who can apply this expertise to the food & beverage, dietary supplement, cannabis, hemp, and psychedelic industries.

Experience in alcohol licensing and regulatory compliance is a must. No cannabis experience is necessary, as we will provide industry-specific training.

This is a key role for an attorney who can manage client matters and develop a new practice area.

Essential Functions and Responsibilities

• Provide legal advice on FDA regulations related to product claims, labeling, manufacturing, advertising, and distribution of cannabis, hemp, and other consumer products.
• Offer strategic guidance on compliance with the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, FTC regulations, and federal and state laws.
• Manage client interactions with federal and state regulators overseeing product development, manufacturing, marketing, and alcohol licensing.
• Work with clients on pre-market strategies, including product development, clinical investigations, and inspection readiness.
• Advise clients on regulatory matters for food, drug, cosmetic, dietary supplements, and alcohol products.
• Act as a liaison with regulatory bodies on product issues, inspections, and inquiries.
• Review product packaging, labeling, marketing materials, and websites for regulatory compliance.
• Supervise associates in FDA, FTC, TTB, and alcohol regulatory compliance work.
• Draft and negotiate agreements related to regulatory requirements, including research contracts and supply agreements.

Qualifications

• Juris Doctorate and bar admission in practicing state(s).
• Minimum of 5 years’ experience in FDA regulatory compliance, with experience representing food, drug, device, and / or alcohol clients preferred.
• Expertise in food and beverage law and alcohol licensing required.
• Understanding of FFDCA, FTC, and GMP regulations preferred.
• Experience advising clients on labeling, advertising, product recalls, GMPs, and agency enforcement actions.
• Strong organizational, communication, and project management skills.
• Experience with Microsoft Office Suite, Adobe Acrobat, NetDocuments, Lexis / Nexis, Westlaw, DocuSign, and Clio preferred.
• Location : Washington DC, NYC, Denver, Boston, LA, or Austin .

Job Environment and Conditions

While performing the duties of this job, the employee is regularly required to talk, write, speak or hear. This position will work in an office environment, conditions are indoors in environmentally controlled conditions.

Must be able to remain in a stationary position for up to 75% of the time. The employee must occasionally lift and / or move up to 10 pounds.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Vicente is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age (40 or older), disability, and genetic information (including family medical history or any other characteristic protected by law.