Associate General Counsel – Regulatory and Technology

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

PATHOS

WebsiteLinkedInAll Job Openings

11 - 50 employees

🛒 Retail

☁️ SaaS

Healthcare • Retail • SaaS

PATHOS is a creative agency that specializes in humanizing brands to build purposeful relationships with people. The company provides full-stack marketing capabilities and connects clients with industry-leading talent and technologies to enhance their brands. PATHOS offers a wide range of services, including custom web applications for healthcare staffing companies, strategic marketing campaigns, brand visibility enhancement for law firms, video storytelling, product launches, and creating bespoke brands for luxury goods. They work across various industries such as healthcare, retail, hospitality, and home building, focusing on innovative and creative solutions to optimize client success.

📋 Description

• Advise on all things regulatory. Drug development, privacy, corporate compliance, AI guidelines, etc. • Own all things regulatory + compliance that don’t already have a home outside Legal. • Maintain organized digital spreadsheets of everything • Advise on FDA regulatory strategy and classification for all components of the AI platform, including implications for development, commercialization, and IND/NDA/BLA submissions. • Advise on protocol development, site monitoring, data integrity, biomarker qualification, companion diagnostic considerations, the use of real-world data, etc. • Monitor and interpret evolving FDA guidance on AI/ML in drug development and translate into actionable guidance for internal teams • Support direct engagement with the FDA and other agencies on novel questions when warranted, including in global clinical programs • Review external content such as conference publications for regulatory issues • Inform and review tech product specs, system architectures, and data flow designs for regulatory risk before build and deployment • Develop working knowledge of the company’s technical stack — cloud infrastructure, data pipelines, storage systems, and model architecture — sufficient to accurately represent those systems to regulators, partners, and investors • Advise on data governance, data integrity, chain-of-custody, and 21 CFR Part 11 requirements for clinical data across company systems and third-party infrastructure • Track and assess evolving AI regulation (EU AI Act, FDA AI governance frameworks, state laws) for applicability to company activities

🎯 Requirements

• J.D. from a top law school and active bar admission • 7+ years of legal experience with substantial in-house time, preferably at a high-growth technology / biotech company • Existing expertise in drug development law: IND/NDA/BLA lifecycle, GCP, 21 CFR Part 11, and regulatory frameworks governing AI/ML tools and software in drug development • Demonstrated experience advising engineering or product teams, with the ability to understand and accurately articulate complex technical systems — cloud infrastructure, data pipelines, ML model architecture — without being a practitioner • Track record of building regulatory strategy from first principles and owning a regulatory and technical narrative with pharma partners, investors, and regulators • Familiarity with clinical data standards, real-world evidence, biomarker qualification, or adaptive trial design.

🏖️ Benefits

• Health insurance • Paid time off • Flexible work arrangements • Professional development opportunities