Manager, REMS

Role: Manager of REMS operations, responsible for the end-to-end execution of Risk Evaluation and Mitigation Strategy programs to ensure patient safety and regulatory compliance. Responsibilities include preparing and submitting FDA REMS filings, managing vendor performance, overseeing compliance and CAPA processes, conducting data reconciliation, monitoring KPIs, addressing FDA inquiries, and supporting audit readiness. The role also involves process improvement, technology enhancement, and ensuring inspection readiness across the REMS portfolio. Qualifications: Bachelor’s in life sciences, health, or business; 5+ years in REMS, pharmacovigilance, or regulatory operations within biopharma; strong understanding of GxP, FDA regulations, and industry best practices. Technical skills include data reconciliation, KPI dashboards, documentation control, and familiarity with GxP systems; experience managing vendors and budgets. Preferred: prior REMS experience, project management certification, audit or inspection background. High-Value: Focus on safety, compliance, and operational excellence in biopharma, with an emphasis on risk mitigation programs impacting cancer or other serious conditions. Cross-functional collaboration with safety, regulatory, and commercial teams; role may involve remote/hybrid work with some travel.