Manager, REMS

Job description

Are you ready to turn regulatory rigor into real patient impact by safeguarding access to transformative medicines? As Manager REMS, you will lead the operational execution of complex Risk Evaluation and Mitigation Strategy programs that protect patients and enable the responsible use of our therapies. Your work will ensure compliant, effective delivery across the REMS lifecycle—keeping programs inspection-ready, data-driven, and aligned with FDA expectations. You will partner closely with REMS leadership, cross-functional teams, and specialized vendors to maintain end-to-end oversight, elevate performance, and resolve risks before they become issues. This role sits at the intersection of safety, commercial execution, and regulatory excellence—where disciplined operations translate into uninterrupted patient access and business continuity. Can you turn complex data into clear decisions that keep mission-critical programs on track? Every improvement you drive—whether in data reconciliation, vendor performance, or submission quality—helps sustain reliable access to medicines for people who need them most, including those living with cancer. If you are energized by high standards, crisp execution, and measurable outcomes, this role offers the scope and responsibility to make your impact felt quickly. **Accountabilities** - FDA REMS submissions: Prepare, coordinate, and deliver high-quality REMS filings and updates on time, ensuring accuracy, completeness, and alignment with company procedures and FDA guidance. - FDA communications: Coordinate, submit, and track all communications to FDA, including information requests, formal correspondence, and submissions for REMS revisions and modifications; maintain complete submission archives. - REMS oversight and governance: Lead ongoing governance of vendor performance, including monthly monitoring of service level agreements, key performance indicators, and critical program metrics; drive remediation when performance deviates. - Compliance management and CAPA leadership: Identify, escalate, and resolve quality issues; document and track corrective and preventive actions, verifying effectiveness and preventing recurrence. - Data oversight and reconciliation: Conduct routine reconciliation across compliance, shipment, and KPI data sources to maintain robust oversight and demonstrate program compliance. - SLA and KPI monitoring and reporting: In partnership with compliance and inspection readiness experts, analyze and report agreed metrics with clear commentary and follow-through on remediation actions. - Inquiry and issue triage: Manage the REMS shared mailbox; respond to inquiries and route questions to the right team members for timely, accurate resolution. - Team operations and program control: Coordinate team meetings, maintain agendas and minutes, and track decisions, risks, and actions against the project plan to sustain program cadence and transparency. - Financial administration: Manage and reconcile invoices against contracts and purchase orders; support timely accruals and budget tracking to ensure fiscal discipline. - Process and tool improvement: Develop, enhance, and maintain reporting tools, processes, and technology solutions that increase efficiency, accuracy, and scalability, including practical integration of AI where it improves outcomes. - Audit and inspection support: Prepare evidence packages and readiness materials; participate in internal/external audits and regulatory inspections, ensuring clear, complete, and defensible documentation. - Continuous improvement and innovation: Standardize and optimize REMS practices, promoting methods that reduce risk, streamline execution, and strengthen inspection readiness across the portfolio. **Essential Skills/Experience** - Bachelor’s degree in a life science, health-related, or business discipline; advanced degree preferred. - 5+ years of experience in REMS operations, pharmacovigilance/patient safety, regulatory operations, or related quality/compliance functions in the biopharmaceutical industry. - Demonstrated understanding of regulatory requirements, guidance, and industry best practices. - Proficiency with data reconciliation, KPI dashboards, and documentation control; strong Excel/analytics skills required; familiarity with relevant GxP systems and document management tools preferred. - Experience managing vendors, contracts, and budgets in a regulated environment. - Strong organizational skills with proven ability to manage multiple priorities, deadlines, and stakeholders. - Excellent written and verbal communication skills with attention to detail and accuracy. - Problem-solving mindset with the ability to identify risks, propose mitigations, and drive issues to resolution. - Comfort working in a matrixed, cross-functional environment. **Desirable Skills/Experience** - Prior REMS experience - Project Management Certification - Audit or Inspection experience - Working with third-party vendors - Proficiency with Microsoft applications **Why AstraZeneca** Here, your expertise powers a mission with urgent, human stakes—bringing life-changing medicines to people sooner and more safely. We unite cutting-edge science with advanced technology and strong investment to push boundaries, especially in earlier disease settings where the right intervention can change the trajectory of health. You will find unexpected teams in the same room unleashing bold thinking, paired with the discipline to deliver and the humility to learn. We value kindness alongside ambition, and we connect individual contribution to a larger purpose: improving outcomes for people living with cancer and other serious conditions while shaping the future of how safety, compliance, and evidence enable patient access. **Call to Action** If you are ready to own REMS execution end-to-end and turn operational precision into patient impact, step forward and help us raise the bar on what compliant, data-driven program leadership can achieve! The annual base pay for this position ranges from $120,355.20 - 180,532.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. **Date Posted** 02-Sep-2026 **Closing Date** 11-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.