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Regulatory Affairs Associate

2 months ago

Washington, United States Jameson Legal Full time

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

Key Responsibilities:
- Offer strategic counsel on regulatory, compliance, transactional, and legislative issues related to the FDA throughout all phases of the product lifecycle.
- 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 transaction teams to address regulatory considerations in mergers and acquisitions, as well as capital market activities.
- Partner with litigation teams to support market access initiatives for products, particularly in matters involving the Administrative Procedure Act.

Advocacy and Legislative Engagement:
- Play a pivotal role in shaping FDA legislative initiatives, advising on legislative strategies, drafting rule-making comments, and participating in hearings and panel discussions.
- Represent clients before key government officials and congressional members overseeing the FDA, Drug Enforcement Agency (DEA), and other federal entities.

For further discussions regarding this opportunity or other positions available, please reach out to the Jameson Legal US Team.