FDA Regulatory Associate Attorney

A law firm in Washington, D.C., is seeking an FDA Regulatory Associate Attorney with 2+ years of experience in advising clients on FDA regulatory matters. The ideal candidate will have experience in product development, clinical trials, product launch and marketing, and interacting with government regulators throughout the FDA-regulated product life cycle. Outstanding writing skills and a keen interest in joining a dynamic and fast-paced practice area are essential.

Duties and Responsibilities:

• Provide legal advice on FDA regulatory issues related to product development, clinical trials, and market launch.
• Advise clients on compliance with FDA regulations and guidelines throughout the product life cycle.
• Assist with the preparation and submission of regulatory filings and applications to the FDA.
• Handle transactional matters involving FDA-regulated entities, including mergers and acquisitions.
• Represent clients in interactions with FDA and other regulatory bodies.
• Conduct legal research and analysis on FDA regulations, policies, and procedures.
• Draft and review regulatory documents, compliance reports, and other related materials.
• Collaborate with internal teams and clients to develop strategies for navigating FDA regulations.
• Stay current with developments in FDA regulations and industry trends.

Requirements:

• 2+ years of experience advising clients on FDA regulatory matters, including transactional matters involving FDA-regulated entities.
• Experience in product development, clinical trials, product launch and marketing, and interacting with government regulators is preferred.
• Outstanding writing skills.

Education:

• Juris Doctor (JD) degree from an accredited law school.

Certifications:

• Admission to the state bar in Washington, D.C.

Skills:

• Strong knowledge of FDA regulations and compliance requirements.
• Excellent written and verbal communication skills.
• Ability to analyze complex regulatory issues and provide practical solutions.
• Experience with FDA submissions and regulatory filings.
• Strong organizational and time-management skills.
• Ability to work effectively in a fast-paced and dynamic environment.
• Collaborative and team-oriented approach.

Boasting a large presence in the corporate and litigation arenas, exceptional training programs, and an innovative partner assessment program, the firm is a major hit with associates. At this firm, associates learn exactly what it means to practice law--and have a breadth of appreciation for all elements of large full-service practice. In their posh DC offices, the environment is professional and polished.