Boutique law firm seeking Associate Attorney with 5 years of regulatory experience. Candidate will manage FDA-related legal and regulatory matters for domestic and international clients.
The primary focuses in this position include 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). Attorneys at Benjamin L. England & Associates, LLC have opportunities to provide direct representation of clients before federal and state agencies and third parties.
DUTIES AND RESPONSIBILITIES:
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
Maintains relevant credentials required for the position. Participates in CLE and maintains leading-edge knowledge and skills in their area of expertise, as required
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 a 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
Additional Salary Information: Based on Experience
Internal Number: AA1
About Benjamin L. England and Associates/FDAImports.com
Benjamin L. England and Associates, LLC, and our affiliated consulting practice, FDAImports.com is celebrating our 10-year anniversary as a legal and regulatory practice, having successfully represented thousands of clients in over 100 countries! Our legal and regulatory professionals assist with FDA, USDA, Customs and various state regulatory requirements for manufacturing, importing, exporting, marketing, advertising and distributing highly regulated foods, beverages, dietary supplements, drugs, cosmetics, and medical devices. Headed by a 17-year veteran of FDA, we have over 100 years of direct FDA/USDA experience in house. Headquartered in Maryland, we maintain satellite offices in California, Florida, and China.
Our professionals are part of a family team, enjoy a business-casual, fast-paced work environment offering substantive variety.
Want to learn more about our firm and how we interact in the industry? Listen to our founder, Ben England: https://youtu.be/NtKx1WJ6YrU
Follow us on Linked In: https://www.linkedin.com/company/benjamin-l-england-&-associates-llc/ and https://www.linkedin.com/company/fdaimports.com-llc/.