We are seeking a highly skilled and experienced FDA & Regulatory Compliance Attorney to join our dynamic legal team. This remote position offers the opportunity to provide expert legal counsel to clients navigating the complex landscape of FDA regulations across various industries, including pharmaceuticals, medical devices, food, and cosmetics. The ideal candidate will possess a deep understanding of federal regulations, a proven track record in compliance, and the ability to work independently and collaboratively in a remote environment.

Key Responsibilities

Provide comprehensive legal advice and strategic guidance on a broad range of FDA regulatory matters, including product development, clinical trials, pre-market clearance/approval, post-market compliance, labeling, advertising, and promotion. Assist clients with the preparation and submission of regulatory applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), 510(k) premarket notifications, Premarket Approval (PMA) applications, and other regulatory filings. Conduct thorough regulatory due diligence in support of mergers, acquisitions, and other corporate transactions, identifying and mitigating potential compliance risks. Develop, implement, and audit internal compliance programs, policies, and procedures to ensure adherence to FDA requirements and best practices. Represent clients in interactions with the FDA, including during inspections, investigations, enforcement actions, and responses to warning letters or other agency communications. Draft, review, and negotiate various agreements, including clinical trial agreements, manufacturing and supply agreements, quality agreements, and distribution agreements, ensuring regulatory compliance. Monitor and analyze new and evolving FDA regulations, guidance documents, and enforcement trends, providing timely updates and strategic recommendations to clients. Advise on Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) compliance. Collaborate effectively with clients, internal teams, and external stakeholders in a fully remote work setting.