REMS Operations Lead: Compliance & Patient Access

AstraZeneca; Los Angeles (CA); On-site; USD 120,000 - 181,000; Full time

Benefits offered by this job

401(k) retirement plan

Health, dental, vision coverage

Paid vacation and holidays

Job summary

AstraZeneca is seeking a Manager REMS to lead the operational execution of complex REMS programs, safeguarding patient access while ensuring FDA-aligned compliance. You will partner with REMS leadership, cross-functional teams, and vendors to maintain end-to-end oversight, drive performance, and mitigate risks before they escalate.

The role emphasizes data-driven decision making, audit readiness, and continuous improvement, translating rigorous safety, regulatory, and commercial objectives into

Qualifications

• Bachelor’s degree or higher in life science, health, or business.
• 5+ years in REMS operations, pharmacovigilance, regulatory operations, or related quality/compliance roles.
• Strong understanding of regulatory requirements and industry best practices.
• Proficiency with data reconciliation, KPI dashboards, and documentation control; Excel/analytics skills required.
• Experience managing vendors, contracts, and budgets in a regulated environment.

Responsibilities

• Prepare and deliver REMS filings and updates on time.
• Coordinate communications with the FDA and maintain submission archives.
• Lead REMS governance, monitor vendor performance and program metrics.
• Identify, elevate, and resolve quality issues; manage CAPAs.
• Reconcile data across compliance, shipment, and KPI data sources.

Skills

REMS operations

Pharmacovigilance

Data reconciliation

KPI dashboards

Excel analytics

Vendor management

Regulatory operations

Communication skills

Education

Bachelor’s degree in life science/health/business

Tools

GxP systems

Document management tools

Microsoft Office

Job description

AstraZeneca is seeking a Manager REMS to lead the operational execution of complex REMS programs, safeguarding patient access while ensuring FDA-aligned compliance. You will partner with REMS leadership, cross-functional teams, and vendors to maintain end-to-end oversight, drive performance, and mitigate risks before they escalate.

The role emphasizes data-driven decision making, audit readiness, and continuous improvement, translating rigorous safety, regulatory, and commercial objectives into