FDA Senior Associate Attorney

Job Title: Senior FDA Regulatory Associate Attorney

Job Overview

A law firm in New York City, NY, is seeking an experienced FDA regulatory attorney to help lead and expand its regulatory compliance practice. This role is ideal for an attorney with a strong background in FDA regulations who can provide expert legal counsel on compliance for companies working with consumer products that include novel ingredients such as hemp, functional mushrooms, and others. The firm works in rapidly emerging sectors like food and beverage, dietary supplements, and more, with an emphasis on ensuring companies meet federal and state regulatory standards.

Duties

• Provide expert legal counsel on FDA regulations, including 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, Public Health Service Act, and Federal Trade Commission regulations, along with federal and state laws.
• Assist clients with interactions involving federal and state regulators for product development, manufacturing, marketing, and alcohol licensing.
• Advise clients on pre-market strategies, including product development, clinical investigations, and readiness for regulatory inspections.
• Guide clients on regulatory requirements for food, drug, cosmetic, dietary supplements, and alcohol-related products.
• Act as the liaison between clients and regulatory bodies on inspections, product issues, and inquiries.
• Review product packaging, labeling, marketing materials, and websites for compliance with regulatory standards.
• Supervise junior attorneys and associates in areas related to FDA, FTC, TTB, and alcohol regulatory compliance.
• Draft and negotiate contracts, including research agreements and supply contracts related to regulatory compliance.

Requirements

• Juris Doctorate
• Active Bar admission in New York
• Minimum of 5+ years of experience in FDA regulatory compliance, with experience representing food, drug, device, or alcohol clients
• Expertise in food and beverage law, as well as alcohol licensing, is essential
• Strong knowledge of FFDCA, FTC, and GMP regulations is preferred
• Experience advising clients on product labeling, advertising, product recalls, GMPs, and enforcement actions by regulatory agencies
• Proficiency with Microsoft Office Suite, Adobe Acrobat, and legal research tools (NetDocuments, Lexis/Nexis, Westlaw)

Education

• Juris Doctorate from an accredited law school
• Bar admission in New York required

Certifications

• Active New York State Bar License

Skills

• Strong organizational and communication abilities
• Excellent project management skills
• Attention to detail and ability to supervise junior staff effectively
• Proficiency in legal research and document management tools
• Ability to manage multiple clients and cases simultaneously

Job Location

• New York City, NY