FDA And Life Sciences Healthcare Associate Attorney

Profile

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

Company info

BCG Attorney Search
1629 K ST NW, Suite 300
Washington
District of Columbia
United States 20006
Phone : (202) 955-5585
Fax : (213) 895-7306