This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role involves leveraging your legal training in a unique and impactful way as an Insurance Compliance Specialist. - Research and amend policy forms to ensure compliance with state and federal regulations. - Support the completion of producer appointments for regulatory adherence. - Gain real-world experience in insurance product development and regulatory compliance. - Work remotely OR in our Dallas office, with full resources for project contributions. Qualifications - Current student or recent graduate from a paralegal program. - Strong academic record with a minimum GPA of 3.0 or a "Pass" in a Pass/Fail system. - Quick learner with excellent research skills and an exceptional eye for detail. - Proven ability to manage high-volume tasks independently and effectively communicate across diverse groups. - Available to work 20-50 hours per week, with flexibility for student schedules. - Must be available for at least 10 hours within normal office hours (7:30 AM - 5:00 PM, Monday through Thursday, and 7:30 AM - 12:00 PM on Fridays). Benefits - Competitive salary and performance-based bonuses. - Flexible schedule to accommodate for classes, exams, etc. - Opportunity for personal and professional development. - A team that values individuality and aims for excellence. Company Description L&E is a leading actuarial consulting firm with over 50 actuaries nationwide and a largely remote yet "high talent" workforce. We've been providing expert services in life, health, and property & casualty insurance since 1968. With a global reach and a commitment to innovation, we deliver tailored solutions for complex financial, risk, and actuarial challenges.

• Develop and lead global Regulatory CMC strategies for investigational and commercial small molecule and ASO products, aligned with development, manufacturing, and commercialization objectives. • Serve as the Regulatory CMC subject matter expert, providing strategic guidance on regulatory risks, timelines, and mitigation plans across the product lifecycle. • Ensure strong cross-functional partnership and alignment with Quality, Analytical, Development, Supply Chain and Commercial Manufacturing teams to support integrated CMC planning and execution. • Author and oversee preparation, review, and submission of CMC sections for INDs, IMPDs, NDAs, and post-approval supplements, ensuring consistency, quality, and regulatory compliance. • Lead and support CMC-related interactions with global health authorities (e.g., FDA, EMA), including meeting strategy, briefing materials, and responses to regulatory inquiries. • Provide regulatory oversight for clinical and commercial manufacturing, including process validation, control strategies, stability programs, and supply continuity. • Lead CMC regulatory strategies for post-approval changes, comparability assessments, technology transfers, and manufacturing site changes. • Build and manage internal Regulatory CMC capabilities and oversee external consultants, CMOs, and regulatory vendors, contributing to scalable processes and governance.

• Support development and execution of global CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director • Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements • Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams to ensure accuracy, alignment, and readiness for submission • Support and participate in health authority interactions, including preparation of briefing documents, responses to information requests, and meeting logistics • Maintain regulatory compliance for CMC activities supporting clinical supply, commercial manufacturing, and ongoing product supply, including stability updates and annual reports • Assist with post-approval change management, including comparability assessments, manufacturing changes, and technology transfers • Manage and coordinate external consultants, CMOs, CROs, and regulatory vendors supporting CMC regulatory activities

• Analyze and provide data from various sources in order to address cost report and other reimbursement filing audits. • Support all third-party cost reports and any analysis, updates, changes. • Coordinate compiling of all data required for completion of any audits. • Conducts research and provides documentation and explanations for all necessary workpapers. • Analyze data from all sources to ensure accuracy, consistency, and technical correctness.