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FDA Regulatory Counsel

2 months ago

Washington, United States Jameson Legal Full time

Position Overview:
This is a remarkable opportunity for a Regulatory Affairs Associate specializing in FDA and Healthcare law. The role involves providing expert guidance to clients as they navigate the complexities of the US Food and Drug Administration's (FDA) regulations within the life sciences sector, which encompasses digital health, medical devices, pharmaceuticals, biotechnology, dietary supplements, food, cosmetics, and other related industries.

Key Responsibilities:
You will be responsible for advising clients on a variety of regulatory, compliance, transactional, and legislative issues pertaining to the FDA throughout all phases of the product life cycle.

This team leverages extensive governmental and industry expertise to deliver informed counsel on intricate and pioneering FDA challenges, ranging from global clinical trial strategies and pre-market approval processes to post-market enforcement actions and product recalls.

The group collaborates closely with corporate deal teams to address regulatory considerations in mergers and acquisitions, as well as capital markets transactions. Additionally, they work alongside litigation teams to support and defend market access for products, particularly in matters related to Administrative Procedure Act litigation.

This team has been instrumental in shaping nearly every significant FDA legislative initiative over the past two decades.

Advocacy and Legislative Engagement:
You will frequently engage in advising on legislative strategies, drafting rule-making comments, participating in hearings and panel discussions, and advocating for clients before high-ranking government officials and congressional members overseeing the FDA, Drug Enforcement Agency (DEA), and other federal entities.

For further insights into this opportunity or other roles we are currently managing, please reach out to the Jameson Legal US Team.