• Manage and maintain all entity and individual licenses nationwide, including producer licenses (Accident & Health (A&H), Property & Casualty (P&C), and Surplus Lines), third-party administrators, managing general agents, and claim adjuster licenses. • Coordinate new applications, renewals, appointments, terminations, and jurisdiction‑specific filings. • Manage and maintain DLRP setup and changes across jurisdictions. • Oversee annual and special regulatory filings with state DOIs. • Monitor, interpret, and communicate regulatory changes affecting licensing, appointments, renewals, continuing education, and state‑specific requirements. • Serve as an internal subject‑matter resource on licensing rules, DRLP requirements, background checks, bonds, and other compliance obligations. • Liaise with Departments of Insurance (DOIs) to resolve escalated or complex licensing issues. • Maintain accurate licensing records in internal systems and third‑party platforms such as NIPR and Sircon. • Track renewal cycles, continuing education deadlines, and compliance calendars with minimal oversight. • Develop SOPs, controls, and audit-ready documentation. • Prepare and deliver reports for leadership, underwriting teams, carrier partners, and auditors. • Identify and implement process improvements to enhance efficiency and scalability.

• Conduct on-site audits and reviews consolidated records • Design, review, and test the revised treatment matrix to identify possible cancers from claims data • Analyze regulatory requirements and identify potential conflicts • Oversee accurate processing, tracking, and filing of federally mandated submissions • Assist with drafting and presentation of programs to researchers • Provide support by reviewing submissions for content • Maintain accurate databases and generate letters • Develop and maintain templates, create files, and mail notices • Adhere to University and unit-level policies and procedures

• Provide regulatory strategy input for small molecule and biologic products • Support regulatory leads in developing contingency plans for CMC-related scenarios • Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads • Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions • Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes • Partner with manufacturing, quality, and external organizations to address CMC-related issues • Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers • Support planning and execution of Health Authority meetings, including mock sessions • Identify and implement process improvements to enhance regulatory efficiency and readiness • Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions • Ensure audit readiness and version control through meticulous documentation and system management

• Evaluate, appropriately process, and respond to external customer inquiries related to product regulatory matters and product safety support. • Support the Sales team with local and global regulatory questions and monitor customer requests. • Identify and appropriately escalate non compliances or missing data in available regulatory information. • Develop and maintain relationships with regulatory contacts at key customers to ensure alignment on submitted regulatory topics. • Coordinate the generation of appropriate documentation to meet internal requirements and external customer needs. • Engage internal teams to review and provide product composition, compliance information, additional substance of concern details, and analytical testing data to support customer safety assessments, regulatory registrations, or licensing processes. • Support the development of standard operating procedures, system enhancements, and global or regional regulatory projects. • Maintain regulatory records and manage and update regulatory systems, databases, and SAP. • Comply with Solenis Health, Safety, and Environment (EHS) policies. • Work collaboratively and effectively in a global environment, often within a dynamic virtual team.