Senior Manager Compliance Operations

Belite Bio•San Diego, CA

About The Position

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs. Built on our proprietary Retinol Binding Protein 4 (RBP4) IP portfolio, our clinical pipeline includes Tinlarebant (LBS-008) , an oral therapy currently in late-stage clinical trials (including the Phase 3 DRAGON and PHOENIX studies) for Stargardt disease (STGD1) and Geographic Atrophy (GA) in dry AMD. At Belite Bio, we are dedicated to developing innovative solutions to treat untreatable conditions and prevent vision loss in patients worldwide. As an early-stage company, we value entrepreneurial thinking, collaboration, accountability and the ability to thrive in fast moving environments. The Senior Manager of Compliance Operations is a member of the Compliance team responsible for managing and improving the day-to-day operational infrastructure that supports Belite Bio’s Compliance Program. Reporting to the Director of Compliance Operations, this role will have primary responsibility for administering and optimizing the Company’s Learning Management System (LMS), including policy and training assignments, curricula support, reporting, compliance metrics, training records, and process improvements that enable effective, timely, and auditable compliance training across the organization. In addition to LMS administration, this position will support key compliance operations activities, including compliance systems maintenance, policy and procedure maintenance, policy approval workflow coordination, third-party compliance operational support, and related documentation, reporting, and process tracking. The role requires strong project management, attention to detail, systems aptitude, cross-functional coordination, and practical compliance judgment to ensure that operational processes are efficient, well-controlled, and aligned with applicable laws, regulations, industry standards, and Company policies.

Requirements

Bachelor’s degree required; degree in Business, Life Sciences, Healthcare Administration, Legal Studies, Compliance, Information Systems, or related field preferred.
Advanced degree or relevant certifications are preferred.
Minimum of 5 years of experience in pharmaceutical, biotechnology, healthcare, or life sciences compliance, with significant experience in compliance operations, training operations, policy management, third-party compliance, or compliance systems administration.
Experience administering or serving as business owner for an LMS or related compliance technology platform required.
Experience supporting a growing or pre-commercial organization, product launch environment, or rare disease business preferred.
Demonstrated ability to build and manage effective relationships within Compliance, as well as other key stakeholders, including Legal, Human Resources, Information Technology, Quality, Commercial, Medical, Finance, Procurement, and external vendors.
Strong systems aptitude, including ability to learn, administer, troubleshoot, document, and improve technology-enabled compliance processes.
Exceptional attention to detail and documentation discipline, with the ability to maintain accurate, complete, and inspection-ready records.
Outstanding verbal and written communication skills, with the ability to distill complex compliance and system requirements into clear guidance, procedures, reports, and training materials.
Ability to thrive in a fast-paced, innovative environment with multiple, conflicting priorities and a substantial workload.
Highly self-motivated, proactive, solution-oriented, and able to quickly gain trust and credibility with team members and business stakeholders.
Strong analytical, organizational, reporting, and process-mapping skills
Knowledge of U.S. laws, regulations, and industry guidance relevant to pharmaceutical compliance programs, including healthcare fraud and abuse laws, federal and state anti-kickback statutes, PhRMA Code, FDA regulations concerning promotional activity, and government agency guidance and enforcement activity.
Demonstrated experience managing or administering a Learning Management System, compliance training platform, policy management system, case management tool, third-party compliance platform, or similar enterprise compliance system.
Strong understanding of compliance operations, training governance, records management, policy lifecycle management, approval workflows, hotline administration, third-party compliance processes, and audit-ready documentation.
Exceptional project management, organizational, analytical, and process-improvement skills, with the ability to manage multiple operational workstreams, deadlines, stakeholders, and system-related priorities.
Excellent communication skills, both oral and written, with the ability to translate compliance requirements into practical operational processes, user guidance, metrics, and reports.
Able to work accurately with an appropriate sense of urgency and function effectively and efficiently in a fast-paced and dynamic environment.
Strong interpersonal skills, including diplomacy, flexibility, collaboration, and the ability to interface effectively across all levels of the organization and with external vendors or partners.

Responsibilities

Serve as the primary administrator and day-to-day business owner for the Company’s Learning Management System, including user access, role-based curricula, course assignments, completion tracking, escalation processes, and training records.
Coordinate within Compliance, as well as other key stakeholders, including Legal, Human Resources, Information Technology, Quality, Commercial, Medical, and functional leaders to confirm training requirements for Company and role-based training, assign training to appropriate audiences, and maintain training matrices aligned to roles, responsibilities, policies, and business activities.
Manage LMS workflows, reports, dashboards, and metrics to track completion, overdue training, recurring assignments, new-hire training, targeted training, and remediation training.
Maintain accurate, complete, and audit-ready training records and documentation, including evidence of assignment, completion, acknowledgments, exceptions, and follow-up.
Support the development, upload, testing, deployment, version control, retirement, and archival of training content in the LMS.
Identify and implement practical improvements to enhance the LMS user experience, streamline administration, improve data integrity, automate manual processes, and strengthen operational controls.
Prepare regular LMS status reports and insights for Company and Compliance leadership, including key performance indicators, training trends, overdue items, and areas requiring follow-up.
Maintain the Compliance policy and procedure inventory, including document lifecycle tracking, review schedules, version control, approvals, publication, acknowledgments, retirement, and archival.
Coordinate policy approval workflows by working with policy owners, reviewers, approvers, Legal, Compliance leadership, and other stakeholders to support timely review and documented approval.
Ensure policies, procedures, and related documents are consistently formatted, current, accessible, and aligned with applicable laws, regulations, industry guidance, Company standards, and operational needs.
Track policy acknowledgments and training requirements in coordination with the LMS, including required follow-up for overdue acknowledgments or training assignments.
Recommend and help implement improvements to policy governance, workflow design, documentation standards, and cross-functional review processes.
Support third-party compliance processes, including due diligence documentation, screening support, training assignment, record maintenance, risk-based follow-up, and ongoing monitoring activities.
Assist Compliance team with operational support, as necessary, including but not limited to assisting with auditing and monitoring support, reporting obligations under State and Federal transparency laws and regulations, price transparency requirements, and other Compliance-related activities.