Search All Food & Drug Administration Attorney Jobs

Washington, D.C. office of an AmLaw firm seeks mid-level FDA associate attorney with 4-6 years of experience in regulations governing foods, dietary supplements, OTC drugs, medical devices, and cosmetics. The ideal candidate must also have significant experience with FTC advertising requirements, claims substantiation, investigations and regulations. Experience with NAD challenges are a plus. Experience in ingredient reviews, label and labeling compliance, advertising claims safety evaluations, substantiation evaluations, 510(k) assessments, recall issues, import/export issues, FDA inspections, civil investigative demand letters, California Proposition 65, good manufacturing regulations for supplements and new dietary ingredient assessments also pluses. Experience with state deceptive practices and investigations are a plus. Legal

The candidate must have strong research and writing skills and excellent academics.

With a longtime DC presence, this strong and reputable firm takes an active role in community and pro bono activities. Recognizing the importance of longevity, this firm goes far to preserve its relationship with its associates. What does that mean for the firm employing hundreds of lawyers in a wide variety of practice areas? It means that associates are well trained and a family atmosphere is fostered. The firm is consistently ranked as one of the top 100 firms and generally considered a great place to work.

Food & Drug Administration

Full-Time

New York City office of an AmLaw firm seeks healthcare/regulatory counsel/ attorney with experience. The candidate must have prior government (FDA or similar government agency) experience as well as experience practicing within the medical device/pharmaceutical manufacturer space. Legal

Lauded as an excellent firm for which to work, this firm has been cited as a top firm for minority and diversity hiring. In the same vein, the firm is praised for its open culture and the wonderful individuals who make it up. Throughout its history, the firm has featured excellent real estate, business, litigation, tax, and employment practices, with the latter being an especially strong suit. With its origins in Los Angeles, the firm has offices across the world and industry-leading clients from over 80 countries, but has not lost its open and friendly culture.

Food & Drug Administration

Full-Time

Washington, D.C. office of our client seeks mid-level FDA regulatory attorney with experience. The candidate must have substantial experience in pharmaceutical and/or medical device regulatory issues, including one or more of the following areas: the Hatch-Waxman and Biosimilars regulatory schemes (approval criteria, labeling, and exclusivities); product development and clinical trials; regulation of advertising and promotion for medical products (including fraud and abuse issues); GMP/QSR compliance and enforcement; device classification, clearance and approval processes. Must have experience in FDA dispute resolution procedures and administrative (APA) litigation. Substantial experience in pharmaceutical and/or medical device regulatory issues is needed. Legal

Transferable skills and a strong academic background from a nationally recognized law school. Exceptional written and oral communication skills are a must.

This Amlaw firm is best known for allowing its associates to find a balanced work load that best suites them. As a result, the company operates with an entrepreneurial culture, offers flexible face-time, and values diversity and a work space inclusive of everyone. This firm is also one that values pro-bono work?encouraging their associates to gain real-life experience and take charge of their own opportunities and success.

Food & Drug Administration

Full-Time

Washington, D.C. office of our client seeks food and drug associate attorney with 2-4 years of experience to work on food, food additive, food packaging matters. The candidate should preferably have experience with FDA rulemaking and regulatory proceedings or those of other federal agencies (such as EPA, USDA, CPSC, FTC or TTB). Legal

The candidate should have strong academic credentials, excellent analytical, writing, and interpersonal skills, and the ability to assume immediate responsibility.

This small to mid-sized firm's expertise lies in the high-tech arena, including pharmaceuticals, chemicals, energy, biotechnology, and e-commerce. Frequently relying on technical consultants, these lawyers are well versed in their clients' industries. The environment is small and fairly casual, with teamwork and cooperation being key themes.

Food & Drug Administration

Full-Time

New York City office of boutique firm seeks FDA/health law attorney with 5-7 years of experience. The candidate will be responsible for: Responding to 483's, FDA Recalls, dealing with FDA Regulatory matters. Evaluating regulatory requirements for compounds, OTC, cosmetics, supplements and legend drugs. Conducting legal research and analyzing data. Drafting evidence based opinions. Concentration in Health Law is preferred. Prior Government experience (FDA and similar agencies a plus) is essential. Must be licensed to practice in NY and in good standing. Licensing in NJ or other states are a plus. Legal

The candidate should have a Juris Doctorate degree (J.D), with excellent academic credentials. Superior research and writing skills are essential. Strong communication skills are needed.

Food & Drug Administration

Full-Time

Chicago office of our client seeks health care and life sciences (FDA regulatory) attorney with 4-6 years of experience. The candidate should have experience representing clients in the life science industry in regulatory and transactional matters, and should have expertise in FDA regulatory matters, fraud and abuse, advertising and promotion, corporate compliance matters and clinical research. Experience negotiating commercial agreements is preferred. Legal

The candidate should possess strong academic credentials and have excellent oral and written communication skills. Juris Doctorate degree is required.

Here is a firm with a strong presence in the Midwest that is well known for its expertise in labor and employment law. The firm actually is considered a trend setter in the areas of labor and employment law, and its attorneys are well known for their abilities in this field throughout the United States. Despite this strong expertise, this firm has grown into a powerful full service firm and has strong practice groups in litigation, corporate, tax, government contracts/technology, bankruptcy, immigration, entertainment, environmental, real estate transactions, employee benefits, estate planning and other areas of law. Associates who have interviewed with this firm are impressed with the fact that the firm appears to do extremely good work and is in a serious growth mode. From our observations, the growth of this firm appears to have been very intelligent and deliberate. Despite the fact that this is a branch office, there do appear to be opportunities for significant associate advancement here.

Food & Drug Administration

Full-Time

Long Island office of our client seeks associate attorney with 5 years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct legal research, analyzing data, drafting evidence-based opinions and providing oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Advise clients and manage with minimal supervision CBP Liquidated Damages Claims Petitions, Offers in Compromise, CBP civil seizure actions, CBP holds, detentions and investigations, CBP requests (CF-28, CF-29), FTA applicability and documentation, and similar CBP and trade-related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining the appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies' regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under Customs, FDA, FAA, USDA, DOT, and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Maintains relevant credentials required for the position. Participates in CLE and maintains leading-edge knowledge and skills in their area of expertise, as required. Must be licensed to practice law in any state and/or the District of Columbia. Prior work experience with FDA and/or other government agencies is preferred. Spanish, Mandarin, Cantonese or Korean language capabilities are preferred. Legal

The candidate should have strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe are essential. Excellent organizational, document and docket management skills are needed. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors are needed. Must be flexible, eager to learn, and able to manage the dynamic environment and rapid change. Should have JD degree from an ABA accredited law school.

Food & Drug Administration

Full-Time

Baltimore office of our client seeks associate attorney with 5 years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct legal research, analyzing data, drafting evidence-based opinions and providing oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Advise clients and manage with minimal supervision CBP Liquidated Damages Claims Petitions, Offers in Compromise, CBP civil seizure actions, CBP holds, detentions and investigations, CBP requests (CF-28, CF-29), FTA applicability and documentation, and similar CBP and trade-related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining the appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies' regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under Customs, FDA, FAA, USDA, DOT, and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Maintains relevant credentials required for the position. Participates in CLE and maintains leading-edge knowledge and skills in their area of expertise, as required. Must be licensed to practice law in any state and/or the District of Columbia. Prior work experience with FDA and/or other government agencies is preferred. Spanish, Mandarin, Cantonese or Korean language capabilities are preferred. Legal

The candidate should have strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe are essential. Excellent organizational, document and docket management skills are needed. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors are needed. Must be flexible, eager to learn, and able to manage the dynamic environment and rapid change. Should have JD degree from an ABA accredited law school.

Food & Drug Administration

Full-Time

Baltimore office of our client seeks FDA regulatory medical products associate attorney with 5 years of regulatory medical products experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will expect to work with primarily in the medical device industry as well as food, dietary supplement, drug, and cosmetic verticals. Conducting legal research, analyzing data, drafting evidence-based opinions and providing oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Advise clients and manage with minimal supervision legal and regulatory matters involving medical device Pre-Market Notification (PMN or 510(k)), de novo review process, and pre-submission meeting processes; the Abbreviated New Drug Application (ANDA), the pre-Investigational New Drug (pre-IND) and IND, and the Drug Efficacy Study Initiative (DESI) evaluation processes; medical device and drug product reviews and classifications; and/or Private and public third-party payor and reimbursement regulations; Medical product labeling reviews; indication for use and directions for use counsel and advice; reviews of monographs, scientific and clinical data and other evidentiary reports; regulations governing wholesale distribution of prescription drugs; importation, exportation and supply management of medical products and medical product components; and similar medical products related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of FDA-regulated products. Communicate effectively, professionally, knowledgeably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining an appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies' regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under FDA, USDA, Customs and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Must be licensed to practice law in any state and/or the District of Columbia. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required. Prior work experience with FDA and/or other government agencies preferred. Spanish, Mandarin, Cantonese or Korean language capabilities preferred. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions; Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe; Excellent organizational, document and docket management skills; Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors; Flexible, eager to learn, and able to manage the dynamic environment and rapid change; Maintains an appropriate firm image in all client communications; Administrative and marketing duties such as drafting blogs, press releases, and presentations, attending conventions, and speaking events is needed. J.D. degree from an ABA accredited law school is required.

Food & Drug Administration

Full-Time

Miami office of our client seeks FDA associate attorney with 5+ years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct legal research, analyze data, draft evidence-based opinions and provide oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Manage FDA-related legal matters independently with minimal supervision including: Advise clients and manage with minimal supervision legal and regulatory matters involving food, food ingredients, the generally recognized as safe (GRAS) notification process, dietary supplements, dietary ingredients, new dietary ingredient (NDI) notifications, food and dietary supplement good manufacturing practices (GMP) regulations recall management and assistance, FDA 483 and Warning Letter response, case management and representation (multiple industries), product labeling reviews; product website and marketing reviews, importation, exportation and supply management of FDA-regulated products; and similar FDA-related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of FDA-regulated products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining an appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies' regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under FDA, USDA, Customs and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Must be licensed to practice law in any state and/or the District of Columbia. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required. Prior work experience with FDA and/or other government agencies preferred. Spanish, Mandarin, Cantonese or Korean language capabilities is preferred. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe. Excellent organizational, document and docket management skills. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors. Flexible, eager to learn, and able to manage the dynamic environment and rapid change. Maintains an appropriate firm image in all client communications. Administrative and marketing duties such as drafting blogs, press releases, and presentations, attending conventions, and speaking events. J.D. degree from an ABA accredited law school is needed. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required.

Food & Drug Administration

Full-Time