Associate: FDA & Healthcare Regulatory

White & Case LLP
235,000
vision insurance, parental leave, 401(k)
United States, Massachusetts, Boston
Feb 23, 2025
Associate: FDA & Healthcare Regulatory Firm Summary White & Case is an elite global law firm serving leading companies, financial institutions and governments worldwide. Our long history as an international firm means we are perfectly placed to help our clients resolve their most complex legal challenges wherever they may be. With lawyers and staff operating from more than 47 locations, working in virtually every country of the world, we have invested heavily in building a high-quality full-service practice competing at the top of the market. We are distinguished by our on-the-ground presence in the world's key financial markets and our strengths in handling complex cross-border work. It's not just about our global network of offices and shared services centers; it's the global interconnectedness of the Firm that our people, and our clients, value most. We work well together across geographic and practice boundaries. It's one of the reasons we attract and retain cross-border work. And why we attract a diverse group of people. Our lawyers are globally minded, enterprising, collaborative and committed to excellence. Diversity is a core value of our Firm and it has been recognized with numerous awards and top rankings around the world. Our people represent 90 nationalities and speak 80 languages. Position Summary White & Case seeks an experienced FDA/healthcare regulatory associate to join our Healthcare & Life Sciences Practice Group. The ideal candidate has a minimum of [two] years of experience advising clients in FDA regulatory matters, including transactional matters involving FDA-regulated entities and experience in healthcare regulatory and compliance areas. The collaborative nature of this team allows attorneys to work closely with clients and in-house regulatory experts to bring exciting new technologies to market. Candidates will work closely with experienced lawyers who will provide active mentoring and opportunities to assume increasing levels of responsibility and client contact. Candidates must be self-starters who possess the ability to work independently and as part of a team. We require strong academic credentials, excellent communication skills, and a commitment to providing the highest quality client service. You will be expected to handle a wide range of responsibilities, including pre-market regulatory assessments, clinical trial issues, due diligence, and post-market product enforcement issues. Ideal candidates have experience interpreting FDA and other healthcare regulatory agency requirements as applied to the life science, medical device and health and wellness industries. Every team member is expected to contribute to the success of our group, and in return will receive excellent opportunities for professional development. Responding to client needs means being flexible about your approach to working hours, and you will have to be comfortable dealing with deadlines. Your practice will require working alongside colleagues from other practices across the firm, including White Collar, Intellectual Property, Corporate and Antitrust. You may be required to manage teams of attorneys and multiple workstreams to accomplish the client's goals. Our Practice Area This team draws on deep legal, regulatory and industry experience to provide seasoned counsel on the most challenging and cutting-edge FDA issues, from global clinical trial and pre-market approval strategies to post-market enforcement actions and recalls. The group also works closely with deal teams to advise on the regulatory aspects of corporate M&A and capital markets transactions, and with litigation teams to defend and facilitate market access to products, particularly in Administrative Procedure Act litigation. Duties and Accountabilities¹ Provide strategic guidance on FDA regulatory compliance across the product lifecycle, from preclinical stages through to commercial product development. Advise on product approvals, labeling, inspections, manufacturing, recalls, 483 responses, adverse event management, and quality agreements. Conduct due diligence for life sciences transactions, especially in acquisitions involving regulatory aspects. Counsel clients on advertising and promotional practices in compliance with DSHEA, Food Drug and Cosmetics Act, and Federal Trade Commission Act for devices, drugs, dietary supplements, biologics, and cosmetics. Offer guidance on additional areas, including state Boards of Pharmacy regulations, state healthcare licensing and regulation. Support telemedicine-based drug delivery compliance and advise in litigation-adjacent roles related to life sciences issues. Conducting complex research and drafting analysis of factual and legal issues Conducting due diligence Communication with clients Assisting develop business strategies and client pitches Basic Qualifications A Juris Doctor (JD) degree (LLM or foreign equivalent) from an accredited law school Admitted to the state bar of the jurisdiction where you are sitting (or the ability to become admitted) and in good standing 2+ years experience working in FDA regulatory compliance, with a focus on healthcare and life sciences Expertise in preclinical and commercial product development, including regulatory submissions, recalls, and adverse event reporting Experience in advising life sciences clients on regulatory and transactional matters Outstanding writing skills Preferred Qualifications Prior experience in a sophisticated law firm, healthcare, or FDA environment Experience in product development, clinical trials, launch and marketing, and with the government regulators at every stage of the FDA-regulated product life cycle Experience with investigations, legal research and writing, persuasive brief writing and oral presentation Strong writing and time management skills are mandatory, as is the ability to stay calm under pressure when juggling multiple projects Outstanding communication skills Location and Reporting This is an associate role in the New York, Washington, DC or Boston office. Equal Opportunities White & Case is an Equal Employment Opportunity (EEO) employer and is committed to creating a diverse and inclusive workplace. It is our Firm's policy to recruit, employ, train, compensate and promote without regard to race, color, religion, creed, national origin, age, gender, sexual orientation, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable law. Applicants who are interested in applying for a position and require an accommodation during the process should contact talent.acquisition@whitecase.com. Benefits at White and Case White & Case LLP offers a comprehensive suite of benefit programs to all eligible employees, including medical, dental, and vision insurance, life and disability coverage, 401(k) retirement savings, vacation time, and leave programs (including parental leave). Exempt roles are also performance bonus eligible. _{The Firm may modify and amend any job description at any time in its sole discretion. Nothing herein creates a contract of employment or otherwise modifies the at-will nature of employment.} _{¹The above is only a general description of the essential duties associated with this position and does not represent an exhaustive or comprehensive list of all duties.} Primary Location : United States-New York Other Locations : United States-Washington D.C., United States-Boston Expected Workplace : Hybrid Job Posting : Dec 4, 2024, 8:54:49 PM Salary range for New York market: 235,000 - 390,000 US Dollars (USD) Yearly Salary range for Washington D.C. market: 235,000 - 390,000 US Dollars (USD) Yearly Salary range in other markets will vary