Regulatory Affairs Associate

2 weeks ago


Washington, United States Jameson Legal Full time

Position Overview:
This role presents a remarkable opportunity for a Regulatory Affairs Associate specializing in FDA and Healthcare law. The successful candidate will provide expert guidance to clients navigating the complexities of the US Food and Drug Administration's (FDA) regulations within the life sciences sector, including areas such as digital health, medical devices, pharmaceuticals, biotechnology, dietary supplements, food, and cosmetics.

Key Responsibilities:
- Offer counsel on regulatory, compliance, transactional, and legislative issues related to FDA oversight throughout the entire product life cycle.
- Leverage extensive government and industry expertise to tackle intricate FDA challenges, from global clinical trial strategies to pre-market approval processes and post-market compliance actions.

Collaboration:
- Work in tandem with corporate deal teams to address regulatory considerations in mergers and acquisitions, as well as capital market transactions.
- Partner with litigation teams to support market access for products, particularly in matters involving Administrative Procedure Act litigation.

Legislative Engagement:
- Actively participate in legislative strategy development, contribute to rule-making comments, and engage in hearings and panel discussions.
- Advocate for clients before key government officials and congressional members overseeing the FDA, Drug Enforcement Agency (DEA), and other federal entities.

This position is integral to shaping FDA legislative initiatives and ensuring clients receive informed and strategic regulatory advice.



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