Associate General Counsel – Regulatory and Technology

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide guidance on various regulatory aspects including drug development, privacy, corporate compliance, AI guidelines, and more.

• Take ownership of all regulatory and compliance matters that do not fall under any other department outside of Legal.

• Keep well-organized digital spreadsheets of all relevant information.

• Advise on FDA regulatory strategies and classifications related to all components of the AI platform, considering implications for development, commercialization, and IND/NDA/BLA submissions.

• Provide counsel on protocol development, site monitoring, data integrity, biomarker qualification, companion diagnostic considerations, and the utilization of real-world data.

• Monitor and interpret the evolving FDA guidance on AI/ML in drug development and translate it into actionable recommendations for internal teams.

• Facilitate direct engagement with the FDA and other regulatory agencies on novel inquiries when necessary, including in global clinical programs.

• Review external materials such as conference publications for regulatory concerns.

• Inform and evaluate technical product specifications, system architectures, and data flow designs for regulatory risks prior to build and deployment.

• Develop a working knowledge of the company's technical infrastructure — including cloud systems, data pipelines, storage solutions, and model architecture — to effectively represent these 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 both company systems and third-party infrastructures.

• Monitor and evaluate emerging AI regulations (EU AI Act, FDA AI governance frameworks, state laws) for relevance to company operations.

⛳️ Requirements

• Juris Doctor (J.D.) from a top-tier law school and active bar admission.

• Over 7 years of legal experience with significant time spent in-house, ideally within a high-growth technology or biotech company.

• Established expertise in drug development law, including IND/NDA/BLA lifecycle, Good Clinical Practice (GCP), 21 CFR Part 11, and regulatory frameworks governing AI/ML tools and software in drug development.

• Proven experience advising engineering or product teams, with the capacity to understand and articulate complex technical systems — such as cloud infrastructure, data pipelines, and ML model architecture — without being a hands-on practitioner.

• A history of constructing regulatory strategies from foundational principles and managing a regulatory and technical narrative with pharmaceutical 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