Head of US Risk Management & Product Safety; Risk Evaluation and Mitigation Strategies-REMS

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The Head of US Risk Management & Product Safety (REMS) provides strategic leadership, oversight, and execution of US Risk Evaluation and Mitigation Strategies (REMS) and local product safety activities across the product lifecycle. This role ensures high quality implementation of risk management programs, operational excellence, regulatory compliance, and optimal patient safety outcomes. The position partners cross functionally with Medical, Regulatory, Commercial, Quality, and Global Safety teams, and serves as the primary US authority on REMS and product safety.

Location:

East Hanover, NJ

• REMS Strategy & Leadership — Lead the design, regulatory development, and launch execution of innovative REMS programs, ensuring operational feasibility and alignment with commercial strategy through collaboration with cross functional leaders.
• Design, execute, and continuous improvement of REMS programs that minimize stakeholder burden while enhancing patient safety
• Lead cross-functional project and product teams across the lifecycle to develop and operationalize evidence-based risk management solutions, including enhanced pharmacovigilance and risk-minimization activities.
• REMS Operational Oversight — Oversee performance and governance of REMS vendors to ensure quality execution, compliance, and data integrity.
• Ensure accurate, timely compliant execution of REMS commitments and assessments, including monitoring of KPIs and escalation of risks.
• US Local Product Safety Management — Serve as the primary US authority for product safety inquiries, escalations, and Health Authority interactions across the lifecycle.
• Oversee safety-related US labeling (USPI, Medication Guides, REMS language) and ensure timely submission of required US aggregate reports.
• Regulatory Compliance & Quality Oversight — Ensure inspection and audit readiness for all REMS and US product-safety operations; lead response management, corrective actions, and CAPA implementation through closure.
• Maintain deep expertise in evolving US regulatory and REMS requirements; translate regulatory expectations into operational guidance.
• Represent the company in FDA interactions, REMS negotiations, advisory committee discussions, and relevant industry forums to advocate for science-based, patient-centric risk management approaches.

• Required:
  
  Bachelor's degree;
  Preferred: advanced degree (Pharm
  
  D, MD, PhD).
• Required:
  
  10+ years' experience in risk management operations, including risk management planning and leadership experience in the pharmaceutical industry.
• Required:
  
  5+ years of leading REMS programs in a matrix role that encompasses managing cross-functional teams across all areas of an organization.
• Required:
  
  Strong knowledge of FDA REMS requirements, US PV regulations, risk minimization strategies, and audit/inspection management.
• Required:
  
  Proven leadership in cross-functional settings; excellent communication, influencing, collaboration, and decision-making skills.
• Required:
  
  Strong executive presence with excellent interpersonal, verbal, and written communication abilities, organizational acumen, and the capability to manage multiple high-priority projects simultaneously.
• Required:
  
  Proven expertise leading large-scale, strategic initiatives related to drug development, risk management and regulatory requirement.
• Required:
  
  Deep understanding of risk management principles and best practices for REMS development implementers, and experience implementing risk management practices and/or managing risk in complex and/or conflict related environments.
• Preferred:
  Familiarity with safety databases, REMS platforms, and data analytics tools.

• Bachelor’s degree; advanced degree preferred (Pharm
  
  D, MD, PhD) or equivalent in related field.