Remote | FDA & Regulatory Compliance Attorney — $140–$400/hour

24-Mag•New York, NY

1d•Remote

About The Position

This remote freelance consulting opportunity is for an experienced attorney to contribute expertise in U.S. FDA law, life sciences regulation, regulatory strategy, and compliance to AI training and evaluation initiatives. The work includes legal research, regulatory risk assessment, technical document analysis, scenario development, and evaluation of AI-generated regulatory content across pharmaceuticals, medical devices, and other regulated life sciences environments. Prior AI experience is not required. The attorney will interpret FDA statutes, federal regulations, guidance, and administrative requirements; review regulatory submissions and compliance documentation; assess regulatory risks and enforcement-related scenarios; and create and evaluate legal training materials. The role also involves producing clear written analyses and feedback, communicating complex requirements to legal, regulatory, technical, and other audiences, and collaborating remotely with project stakeholders. Work must not use confidential or proprietary information belonging to an employer, client, institution, or other third party. The engagement is freelance/contract, fully remote, and pays $140–$400 per hour. Five openings are available. The opportunity is offered through 24-MAG LLC, which connects professionals with remote consulting opportunities.

Requirements

Juris Doctor (JD) degree.
Active licence to practise law in the United States.
At least 5 years of professional experience focused on FDA law, regulatory compliance, or regulatory strategy.
Strong legal expertise in the pharmaceutical, medical device, biotechnology, or broader life sciences industries.
Comprehensive understanding of FDA statutes, federal regulations, regulatory guidance, and administrative processes.
Practical knowledge of regulatory submission pathways, compliance protocols, and agency expectations.
Demonstrated experience reviewing regulatory documentation, interpreting legal requirements, and conducting detailed legal research.
Strong ability to identify regulatory risks, compliance deficiencies, and potential liability considerations.
Excellent legal writing, analytical reasoning, problem-solving, and attention-to-detail skills.
Ability to interpret complex or ambiguous regulatory requirements and explain findings clearly and actionably.
Outstanding written and verbal communication skills, including experience communicating with legal, regulatory, and technical stakeholders.
Ability to work independently and contribute to remote collaborative research assignments.
Must complete work without using confidential or proprietary information belonging to an employer, client, institution, or other third party.

Nice To Haves

Experience advising or representing clients in FDA investigations, warning letter responses, or consent decree matters.
Familiarity with emerging regulatory developments and evolving compliance expectations across regulated life sciences sectors.

Responsibilities

Analyse and interpret FDA statutes, federal regulations, guidance documents, and administrative requirements.
Conduct legal research across pharmaceutical, medical device, and broader life sciences regulatory frameworks.
Evaluate regulatory requirements affecting product development, approval pathways, marketing, and ongoing compliance.
Review FDA regulatory submissions, compliance documentation, and procedural materials for accuracy, completeness, regulatory consistency, and alignment with applicable requirements.
Analyse submission pathways and associated legal obligations, and identify documentation issues, inconsistencies, and matters needing clarification.
Assess legal scenarios involving FDA compliance risks, enforcement trends, and potential liability considerations, including inspections, investigations, warning letters, corrective actions, and remediation.
Identify emerging regulatory developments and assess their implications for life sciences organisations.
Develop realistic legal questions, scenario-based exercises, and case studies reflecting FDA regulatory practice.
Review, edit, and validate AI-generated regulatory explanations, analyses, and compliance-related responses; identify inaccuracies or incomplete reasoning and provide constructive feedback.
Prepare regulatory analyses, research summaries, scenario assessments, and structured evaluation feedback.
Communicate complex legal and regulatory concepts to technical and non-technical audiences.
Collaborate remotely with project stakeholders and contributors, and support improvements to research methods, content accuracy, and deliverable quality.