Does research, data analysis, drafting and editing specialized documents, and providing invaluable support to the heart of a boutique law firm sound like an ideal day at the office? Well, we have a proposition for you!
The Regulatory Specialist will work in collaboration with attorneys, advisors, and independently to perform research, evaluate data, prepare filings, and support in providing advice and counsel to our clients regarding Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Customs and Border Patrol (CBP), and other government agencies regulatory compliance requirements.
DUTIES AND RESPONSIBILITIES:
Read, analyze, and interpret laws, regulations, and policies under FDA, USDA, CBP, and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents.
Perform technical reviews of client files and product labels, draft permit and licensing applications to government agencies, and evidence-based opinions influencing successful importation or exportation of product(s).
Communicate effectively, professionally, knowledgeably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining appropriate Firm image.
Coordinate, compile, modify, and draft written responses to federal and local regulatory agencies, principally FDA.
Draft reports and procedure manuals that conform to the prescribed style and format for the purposes of implementing and improving regulatory processes.
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 identified product(s) into compliance.
Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions.
Flexible, eager to learn, and able to manage dynamic and rapid change.
Extremely detail-oriented with a high capacity for multi-tasking.
Excellent communication and mechanical writing skills free of typographical, grammar, and punctuation errors.
Excellent clerical 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.
Bachelor’s degree in a science-related discipline strongly preferred.
Telecommuting is allowed.
Internal Number: RS-2020
About Benjamin L. England and Associates, LLC
Benjamin L. England and Associates, LLC, and our affiliated consulting practice, FDAImports.com, have 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 LinkedIn: https://www.linkedin.com/company/benjamin-l-england-&-associates-llc/ and https://www.linkedin.com/company/fdaimports.com-llc/.