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FDA Regulatory Attorney

BCG Attorney Search

This is a Full-time position in Los Angeles, CA posted June 2, 2021.

Los Angeles office of a BCG Attorney Search Top Ranked Law Firm seeks FDA regulatory attorney with 3-4 years of experience representing food, drug and/or device clients or commensurate experience working at the FDA preferred.

The candidate will be 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.

Will also maintain up to date knowledge of industry laws and regulations applicable to cannabis containing foods and beverages 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.

Must be licensed attorney in practicing state.

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 and Drug Administration Import Operations preferred.

Public-policy and advocacy experience relating to FDA-regulated products preferred.

Should have 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.

Experience with Microsoft Office Suite, Adobe Acrobat, NetDocuments,Lexis/Nexis, Westlaw, DocuSign and Clio preferred.

The candidate should have Juris Doctorate degree.

Must have 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 essential.

Excellent oral and written communication skills needed.

Founded a decade ago, this national cannabis law firm provides legal and policy services to cannabis and hemp businesses, ancillary companies, investors, and governmental bodies.

The attorneys have years of extensive experience working with businesses, advocates, and government officials on a wide variety of legal and policy matters and have helped governments shape regulations at the local, state, and national levels.

Many members of the team are widely recognized as leaders in cannabis law and policy and frequently appear in national and local media.

The firm is ranked by Chambers and Partners in the USA as Nationwide: Cannabis Law, also was included in the 2020 list of Top Cannabis Law Firms compiled by Green Market Report and Cannabis Law Report.

The firm provides a supportive and stimulating culture, and opportunities for long-term personal and professional development.

The firm’s benefits include health insurance, 401 (K), employee equity incentive plan, paid time-off and holidays, fitness membership reimbursement, paid parental leave, employee referral program, and ongoing professional development and coaching.

Your information will not be forwarded to any employers at this time.

A recruiter will contact you with more information once our internal review of your resume is completed.

Los Angeles office of a BCG Attorney Search Top Ranked Law Firm seeks a junior to mid-level pharmaceutical and biotechnology associate attorney.

The candidate will work with other attorneys at the firm who specialize in the regulation of pharmaceutical and biotechnology products by the US Food and Drug Administration (FDA).

Will draft and negotiate….

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