FDA Regulatory Attorney Vicente Sederberg LLP Washington, DC

Salary $150,000 – $215,000 a year

Job Type Full-time

Number of hires for this role 1

Qualifications

- Doctorate (Preferred)
- US work authorization (Preferred)

Full Job Description

Top cannabis law firm looking for FDA regulatory attorney. Unique chance to specialize in a unique area of law and policy by working with a top mission-driven industry law firm. We are looking for a attorney with three-four years of experience in food and drug law regulation who is able to apply this knowledge to cannabis regulation. No cannabis experience necessary, we will teach you everything you need to know.

This position is responsible for managing client matters by ensuring clients remain in compliance in a highly regulated industry, and by helping clients navigate the complex and evolving regulatory framework for cannabis containing foods and beverages. This position will also maintain up to date knowledge of industry laws and regulations applicable to cannabis containing foods and beverages, Associate can be based in Washington DC, NYC, Denver, Boston, LA or Austin.

Vicente Sederberg offers competitive salaries and a comprehensive benefits package including Medical, Dental, Vision, Life, AD&D, STD and LTD Insurance coverages 100% paid for by Vicente Sederberg for all of our full-time employees. 401k with 4% company match, unlimited paid time off plan for attorneys, fitness membership reimbursement, paid parental leave and employee equity incentive plan!

Vicente Sederberg is a team that values diversity of all stripes. We warmly welcome individuals to our team from all different backgrounds and promote an accepting culture and environment. We especially strive to include those who have been historically disadvantaged.

Responsibilities of our Regulatory Associates include but are not limited to:

Provide legal advice and guidance on compliance with FDA regulations related to advertising and promotion, product claims, labeling, manufacturing,and sale and distribution of hemp and marijuana products.
Provide strategic counseling and skillful advocacy to companies, subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, FTC and related federal and state laws specific to cannabis products.
Manage client interactions with federal and state regulators who oversee product development, manufacturing, and marketing activities.
Work with clients to develop pre-market strategies and their implementation, including product development, clinical investigations, expedited review and approval pathways, orphan drug and other designations, premarket applications, dispute resolution and appeals, label negotiations, commercial launch preparation, and inspection readiness.
Work with clients to advise on best practices and legal considerations for early-stage food, drug, cosmetic, and dietary supplement products.
Act as a liaison with government regulatory bodies and administrative agencies on behalf of clients regarding product issues, inspections, and inquiries.
Answer complex compliance questions incorporating nuanced areas of state, local, and federal law and provide insight on enforcement and policy trends.
Review packaging, labeling, and marketing materials for compliance.
Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions.
Supervise associates in FDA, FTC, and regulatory compliance work.
Draft, negotiate, and provide guidance related to regulatory requirements relating to commercial agreements, including third-party research, contract manufacturers and suppliers, and sales and distribution.
Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions.

Qualifications:

Juris Doctorate required.
Licensed attorney in practicing state(s) required.
Minimum of 3 years’ experience in FDA regulatory and compliance representing food, drug and/or device clients or commensurate experience working at the FDA preferred.
Food and beverage law expertise preferred.
Comprehension of FFDCA and FTC, with experience in quality assurance and GMP preferred.
Comprehension of regulations relating to cosmetics, OTC products, and/or consumer products including U.S. Customs and Border Protection and Food & Drug Administration Import Operations preferred.
Public-policy and advocacy experience relating to FDA-regulated products preferred.
Experience advising clients on labeling, advertising and promotion, adverse event reporting, product recalls, good manufacturing practices (GMPs), agency inspections and remediation of inspection findings as well as responding to agency enforcement actions.
Passion for providing unparalleled client service.
Experience with Microsoft Office Suite, Adobe Acrobat, NetDocuments,Lexis/Nexis, Westlaw, DocuSign and Clio preferred.
Exceptional organization skills, strong self-motivator with high attention to detail.
Excellent time and deadline management skills in fast paced environment, ability to juggle multiple projects and reprioritize quickly and efficiently.
Excellent oral and written communication skills.

Qualified applicants please send your cover letter, resume and salary requirements to be considered.

Vicente Sederberg is an equal opportunity employer and does not discriminate on the basis of race, religion, color national origin, age, sex, gender, sexual orientation or identity, disability or any other characteristic protected by law.

Job Type: Full-time

Pay: $150,000.00 – $215,000.00 per year

Benefits: