FDA And Life Sciences Healthcare Associate Attorney

Position Title: FDA and Life Sciences Healthcare Associate Attorney

Job Overview:
An established law firm in Washington, DC, seeks an experienced FDA and Life Sciences Healthcare Associate Attorney to provide expert regulatory and compliance counsel. This role supports a diverse client base across the healthcare and life sciences industry, contributing to regulatory strategy and offering compliance insights on critical FDA and healthcare regulatory matters.

Duties:

• Offer regulatory guidance from preclinical to post-commercial stages of product development.
• Advise on FDA product approvals, labeling, inspections, and compliance with manufacturing and recall processes.
• Assist in responding to 483 observations, managing adverse events, and maintaining quality agreements in drug and device manufacturing.
• Conduct due diligence on life sciences acquisitions, focusing on DSHEA, Food Drug and Cosmetics Act, and Federal Trade Commission Act compliance.
• Counsel on advertising and promotional regulations for medical devices, drugs, dietary supplements, biologics, and cosmetics.
• Provide additional advisory on state Board of Pharmacy regulations, FDA market denial orders, and life sciences IPOs.
• Support cannabis licensure and regulation compliance, telemedicine-based drug delivery, and life sciences litigation support.

Requirements:

• Minimum of 3-5 years of FDA regulatory compliance experience, ideally within the life sciences sector.
• Proven background in regulatory aspects of the healthcare industry, particularly regarding FDA rules, product development, and compliance standards.
• Practical understanding of state pharmacy board regulations, credit agreements, and market regulations for life sciences.
• Experience with cannabis licensure, telemedicine, and advisory in litigation for life sciences is a plus.

Education:

• A Juris Doctor (JD) from an accredited law school.
• The academic distinction in relevant fields, with coursework in healthcare or life sciences, is preferred.

Certifications:

• Bar membership in good standing in any U.S. jurisdiction, with preference for Washington, DC.

Skills:

• Exceptional writing and research skills.
• Strong analytical abilities to interpret complex regulatory frameworks.
• Ability to manage multiple clients and cases within a high-paced law firm setting.

Job Location:

• Washington, DC

Although it is a full-service firm, this organization seems to excel when it comes to the more specialized practice areas, such as environmental, regulatory and energy practices. The representation of Mid-Atlantic technology clients is rewarding for the firm as well. In keeping with this theme, the firm utilizes state of the art communications equipment and computers in order to streamline work efforts and reduce costs for the firm and its clients. Associates will appreciate the fact that the firm is filled with a fairly diverse crowd and that salaries are merit-based, rather than lockstep.