FDA & Healthcare Regulatory Associate – Washington, DC

This is an excellent Washington, DC-based opportunity for an FDA and Healthcare Associate Attorney to advise clients navigating the US Food and Drug Administration’s (FDA’s) oversight and regulation of the life sciences industry, including digital health, medical device, pharmaceutical, biotechnology, dietary supplement, food, cosmetic, and other life sciences industry clients. You will counsel clients on regulatory, compliance, transactional, and legislative matters involving the FDA across all stages of the product life cycle. This team draws on deep government and industry experience to provide seasoned counsel on the most challenging and cutting-edge FDA issues, from global clinical trial and pre-market approval strategies to post-market enforcement actions and recalls. The group also works closely with deal teams to advise on the regulatory aspects of corporate M&A and capital markets transactions, and with litigation teams to defend and facilitate market access to products, particularly in Administrative Procedure Act litigation. This group has played a central role in nearly every FDA legislative initiative of the past two decades. You will routinely advise on legislative strategies, write rule-making comments, participate in hearings and panel meetings, and advocate for clients before senior government officials and members of Congress overseeing the FDA, Drug Enforcement Agency (DEA), and other US federal agencies.

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