Greenberg Traurig (GT), a global law firm, has an exciting full-time employment opportunity for a 3rd-6th year associate to join a life sciences/product regulatory group within the Health Care Practice of our DC office. We offer competitive compensation and an excellent benefits package. GT is consistently among the top firms on the Am Law Global 100; the associate will have the opportunity to work with clients, large and small, from a variety of industries across the world.

Responsibilities

• Advise life sciences, biotechnology, and technology clients on U.S. FDA or other regulatory matters, including product development, approval pathways, commercialization strategies, and life-cycle management

• Support complex cross-border regulatory strategy or corporate transactions, including mergers and acquisitions, strategic alliances, and licensing

• Conduct regulatory due diligence in connection with transactional matters involving advanced technology and life sciences companies

• Assist clients in developing and implementing compliance strategies across multiple jurisdictions, including the United States, Europe, and Asia

• Monitor and analyze legislative and regulatory developments affecting clients' businesses and prepare client alerts, memoranda, and strategic guidance

Required Qualifications

• Three to six years of experience at a law firm, government agency, or comparable in-house legal department

• Substantive experience in life sciences product regulatory law, including familiarity with FDA regulatory pathways and compliance requirements

• Demonstrated ability to manage complex matters and work effectively in a fast-paced, client-driven environment

• Strong research, writing, and analytical skills with the ability to distill complex regulatory issues into clear, actionable advice

• Admission to one or more state bars is required

Preferred Qualifications

• Experience with cell and gene therapy, immuno-oncology, or advanced biotechnology regulation

• Familiarity with CMS reimbursement and pricing frameworks, including coverage determinations, coding, and payment policy as they relate to innovative life sciences products

• Experience advising on cross-border regulatory matters in one or more international markets

• Familiarity with national security and trade policies impacting the life sciences and semiconductor sectors

• Professional fluency in Japanese or Mandarin is a strong plus

Submissions from search firms will only be accepted through our web portal for third-party submissions; for access, contact Mike Balzotti.

The expected pay range for this position is:

$260,000 - 390,000 per year

Actual pay will be adjusted based on experience, location, and other job-related factors permitted by law.  Full time employees may be eligible for a discretionary bonus, health insurance with an optional HSA, short term disability, long term disability, dental insurance, vision care, life insurance, Healthcare and Dependent Care Flexible Spending Accounts, 401K, vacation, sick time, and an employee assistance program.  Additional voluntary programs include:  voluntary accident insurance, voluntary life, voluntary disability, voluntary critical illness and cancer insurance and pet insurance.  Commuter and Transit programs may also be available in certain markets.

GT is an EEO employer with an inclusive workplace committed to merit-based consideration and review without regard to an individual’s race, sex, or other protected characteristics and to the principles of non-discrimination on any protected basis.