Senior FDA Associate Attorney

Job Title: Senior FDA Regulatory Attorney

Job Overview: A distinguished law firm located in Austin, TX is seeking an experienced FDA regulatory attorney. This role provides a unique opportunity to lead and expand a regulatory compliance practice focused on industries that develop and sell consumer products with novel ingredients such as hemp, functional mushrooms, and more. The ideal candidate will manage client matters and contribute to the development of a new practice area within the firm.

Duties:

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

Requirements:

• Juris Doctorate (JD)
• Licensed to practice law in Texas
• Minimum of 5+ years of experience in FDA regulatory compliance
• Proven experience working with food, drug, device, and/or alcohol clients is preferred

Education:

• Juris Doctorate from an accredited law school

Certifications:

• Bar admission in Texas required

Skills:

• Expertise in food and beverage law and alcohol licensing
• Strong understanding of FDA, FTC, and GMP regulations
• Proficient in advising clients on labeling, advertising, product recalls, and regulatory enforcement actions
• Exceptional organizational, communication, and project management skills
• Proficiency with legal research tools and software such as Microsoft Office, Adobe Acrobat, Lexis/Nexis, Westlaw, and document management systems like NetDocuments and Clio

Job Location:

• Austin, TX