Manager, REMS
Core
Lead operational execution of FDA Risk Evaluation and Mitigation Strategy (REMS) programs to ensure compliant, effective delivery of patient safety measures for transformative medicines.
Role type
Manager, Regulatory Operations (REMS)
Builds
End-to-end oversight of REMS lifecycle, vendor performance, and regulatory submissions for biopharmaceutical therapies.
Domain
Biopharmaceuticals / Regulatory Compliance / Patient Safety
Deliverable
client delivery
Required skills
REMS operations, pharmacovigilance, regulatory operations, vendor management, contract and budget management, data reconciliation, KPI dashboarding, GxP systems, document management, audit and inspection support, process improvement
Preferred skills
Project Management Certification, advanced degree in life science/health/business, experience with third-party vendors, Microsoft applications proficiency
Technologies
GxP systems, document management tools, Excel, Microsoft applications
Responsibilities
Prepare and coordinate FDA REMS submissions and updates; manage vendor performance and SLA/KPI monitoring; lead compliance management and CAPA; conduct data reconciliation across compliance and shipment sources; manage REMS shared mailbox and issue triage; coordinate team operations and program control; manage financial administration including invoices and budgets; support audit and inspection readiness; drive continuous improvement and innovation in REMS practices.
Seniority
Manager, hands-on IC with team coordination
