Senior FDA Associate Attorney

Senior FDA Regulatory Compliance Attorney

Job Overview:
A prominent law firm in Boston, MA, is currently seeking an experienced FDA regulatory compliance attorney. This position provides a unique opportunity to lead and expand a regulatory compliance practice, specifically supporting businesses in the consumer products sector, including those involved in hemp, functional mushrooms, dietary supplements, and other novel ingredients. The role requires advising on a wide range of regulatory matters and managing client relationships with federal and state regulatory bodies.

Duties:

• Provide legal counsel on FDA regulations, including product claims, labeling, manufacturing, advertising, and distribution of consumer products, including cannabis and hemp.
• Offer strategic compliance advice regarding the Federal Food, Drug, and Cosmetic Act, FTC regulations, and related federal and state laws.
• Manage interactions with federal and state regulators concerning product development, manufacturing, and marketing.
• Advise clients on pre-market strategies, including product development, clinical investigations, and regulatory inspection preparedness.
• Oversee regulatory matters related to food, drugs, cosmetics, dietary supplements, and alcohol products.
• Act as the primary liaison with regulatory agencies on product-related issues, inspections, and compliance inquiries.
• Review and approve packaging, labeling, marketing materials, and websites for regulatory compliance.
• Draft, negotiate, and manage contracts related to regulatory requirements, such as research agreements and supply contracts.
• Supervise associates on matters related to FDA, FTC, and alcohol regulatory compliance.

Requirements:

• Minimum 5+ years of experience in FDA regulatory compliance, particularly in the food, drug, device, or alcohol industries.
• Experience advising clients on labeling, advertising, product recalls GMPs, and agency enforcement actions.
• Strong project management and organizational skills.

Education:

• Juris Doctor (JD) degree required.
• Must be a member of the Massachusetts Bar.

Certifications:

• Active Bar admission in Massachusetts.

Skills:

• Extensive knowledge of FDA, FFDCA, FTC, and GMP regulations.
• Proficiency with regulatory compliance software and legal research tools, such as Westlaw, LexisNexis, and Microsoft Office.
• Strong communication and analytical skills.
• Ability to manage client relationships and lead regulatory compliance teams.

Job Location:

• Boston, MA

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.