Manager, REMS Center of Excellence

Sandoz

Manager, REMS Center of Excellence managing risk evaluation strategies for Sandoz's generic and biosimilar portfolios. Collaborating internally and externally to ensure regulatory compliance and effective risk management.

Posted 6/6/2026full-timeRemote • New Jersey • 🇺🇸 United StatesJuniorMid-Level💰 $91,400 - $169,700 per yearWebsite

About the role

Key responsibilities & impact

Manage Risk Evaluation and Mitigation Strategies (REMS) in the Sandoz generic and biosimilar portfolios
Serve as the Sandoz safety REMS expert on project/product teams throughout the product life cycle
Provide oversight of the tactical implementation and monitoring of REMS commitments
Work closely with internal business units, including Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance
Drive execution of REMS development, implementation, and operationalization according to agreed strategies
Develop and manage vendor contracts
Manage REMS budgets, review and approve vendor invoices, and program deliverables
Ensure compliance with REMS regulatory requirements and reporting
Coordinate REMS training across the organization

Requirements

What you’ll need

RN, MS, MPH, MBA, or BS with considerable experience
Minimum of 2 years supporting REMS programs
Advanced knowledge of FDA REMS requirements, regulatory expectations, and evolving risk-mitigation standards
Skilled in establishing productive relationships with vendors, healthcare partners, and internal teams
Expertise in streamlining workflows, optimizing resource allocation, and leveraging data-driven decision-making
Deep understanding of project management methodologies and best practices
Ability to develop and execute high-level strategies for product launches
Minimum of 5 years in pharmaceutical industry (preferred)

Benefits

Comp & perks

Health insurance coverage for medical, prescription drugs, dental and vision
Generous company match for retirement savings accounts
Generous paid time off
Hybrid work policy that combines a mix of in-person and remote work

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

REMS managementFDA REMS requirementsrisk-mitigation standardsproject management methodologiesdata-driven decision-makingvendor contract managementbudget managementregulatory compliancetactical implementationmonitoring of REMS commitments

Soft Skills

relationship buildingcollaborationstrategic thinkingresource optimizationworkflow streamliningcommunicationoversighttraining coordinationexecutionleadership

Certifications

RNMSMPHMBABS