Healthcare Associate

Description:

One of the nation’s most prominent and highly regarded healthcare and life sciences legal teams is seeking Associate Attorneys with 3 to 5 years of experience in FDA regulatory compliance and life sciences law. The ideal candidates will bring a comprehensive understanding of the complex regulatory landscape surrounding medical, pharmaceutical, biotech, and health-related product development and commercialization.

This position offers the opportunity to work at the forefront of the life sciences industry, serving clients ranging from early-stage biotech startups to large pharmaceutical corporations. Associates will be involved in advising on critical regulatory matters and supporting clients through every phase of product development—from preclinical stages to commercial launch and beyond.

Key Responsibilities:

• Provide counsel on FDA regulatory compliance issues across product life cycles: development, approval, labeling, manufacturing, inspections, recalls, and post-market obligations

• Advise on FDA 483 responses, adverse event reporting, quality agreements, and contract manufacturing issues for drugs and devices

• Conduct legal due diligence for acquisitions and equity financings in the life sciences space

• Counsel clients on compliance with DSHEA, the Federal Food, Drug, and Cosmetic Act, and the Federal Trade Commission Act

• Evaluate and advise on advertising and promotional practices related to drugs, medical devices, dietary supplements, biologics, and cosmetics

• Interpret and advise on state Boards of Pharmacy regulations and licensure issues

• Support market denial order responses, IPO regulatory due diligence, and telemedicine-based pharmaceutical delivery

• Provide legal guidance in litigation-adjacent roles involving regulatory matters in life sciences

• Maintain up-to-date knowledge on emerging regulatory issues and industry trends

• Communicate complex regulatory guidance to clients clearly and effectively

Preferred Background & Qualifications:

• Demonstrated experience advising life sciences clients with a deep understanding of their operations and needs

• Prior experience at a sophisticated law firm, FDA, or a life sciences company is highly valued

• Academic background in life sciences or healthcare law strongly preferred

• Familiarity with cannabis licensing/regulatory regimes is a plus

• Strong academic credentials from a top-tier law school

• Excellent written and oral communication skills

• Must be admitted to the Bar in the state corresponding to the office location