Jobs at Regeneron

Manage regional clinical study delivery in collaboration with Clinical Study Lead, CROs, and vendors. Oversee study documentation, systems (CTMS, TMF, EDC, IVRS/IWRS), vendor contracting, recruitment/retention, data quality, budgeting, timelines, and close-out activities while ensuring ICH/GCP and inspection readiness.

Manage creation, revision, and retirement of product specification documents; ensure compliance with regulatory filings and site procedures; perform quality risk assessments; support deviation investigations; collaborate cross-functionally to define specification content and assess change impact; present updates in meetings and help resolve project issues. Knowledge of biopharma testing, USP/EP compendia, and ICH guidelines is desirable.

Provide business-facing application support for validated IT systems: troubleshoot application/server issues, maintain documentation, process change controls with Validation/Quality, configure reports, perform user administration, support inspections, conduct access and audit reviews, and coordinate system implementations with stakeholders.

Lead corporate security intelligence program: conduct all-source collection and analysis (counterintelligence, IP/trade secrets, fraud, insider threat, cyber), produce intelligence products and threat assessments, support investigations and executive protection, fuse OSINT and partner data, create dashboards and risk maps, and coordinate with resilience, information security, law enforcement and external intelligence networks.

The Associate Scientist will prepare and stain mouse splenocytes, perform FACS, analyze flow cytometry data, and document results while collaborating within the lab environment.

Manage and track Process Sciences change controls and supplier change notifications to ensure cGMP compliance. Coordinate cross-functional implementation, evaluate supplier changes, lead meetings, present impactful changes to leadership, and report key metrics to support manufacturing operations and regulatory timelines.

Partner with cross-functional teams to manage IOPS program budgets, forecasting, COGS/COCM modeling, variance analysis, and collaboration finances. Lead re-forecasts, respond to ad-hoc requests, support strategic planning, and drive financial guidance for manufacturing and program decisions.

Lead cross-functional IT programs for Research and Preclinical Development, manage project roadmaps, risks, and dependencies, support portfolio governance and reporting, coordinate stakeholders, vendors, and technology teams, and present program updates to leadership to ensure timely delivery of strategic initiatives.

Perform calibration, troubleshooting, loop checks, tuning and startup of instrumentation (temperature, pressure, level, flow, analytical) in a cGMP facilities environment; maintain CMMS and paper records, adhere to SOPs and trainings, support continuous improvement and liaise with Facilities, QA, Engineering and Operations. 24/7 shift onsite in Raheen, Limerick.

Lead a team to drive site data governance culture: design and deliver DG training, engage stakeholders and data stewards, build KPIs, monitor and audit DG practices, and collaborate with technical and business partners to continuously improve compliance with data integrity and GMP/GDP requirements.

Lead centralized capital organization and governance for a large biotech capital portfolio. Oversee project controls, Front-End Planning, cost/schedule/risk management, portfolio analytics, and cross-functional alignment. Drive long-range capital planning, governance frameworks, KPIs, AI/ML analytics, and continuous improvement across projects and sites.

Support configuration, testing, and documentation for Oracle Fusion, Oracle EBS, and adjacent systems. Assist with SIT/UAT, defect tracking, data validation, change control, and integration coordination while building functional ERP knowledge under senior guidance.

Lead end-to-end analysis, design, and delivery for Oracle Fusion/EBS implementations and integrations. Author FDDs/TDDs/BPDs, design RICEFW objects, manage integration with platforms (Boomi, Kinaxis, Maximo, MES), and ensure GxP/CSA/21 CFR Part 11 compliance. Own system documentation, testing artifacts, change control, and project governance. Mentor junior team members and support hyper care, audits, and validation activities in a regulated pharmaceutical environment.

Lead international commercial analytics and market research for Neurology across Europe, Japan and Canada. Deliver performance reporting, customer insights, patient cohorts, forecasting, segmentation, account-level opportunity assessments, and partner with Commercial Operations, IT and vendors to centralize data and inform strategic decisions.

Serve as technical SME for lab IT applications: lead configuration, implementation, integrations, and change control. Partner with Validation, Quality, automation teams and vendors to ensure compliant deployments, configure reports and security reviews, provide on‑floor support and troubleshooting, train and prioritize work for analysts, and support cloud/hybrid architectures in a regulated/GMP environment.

Provide administrative, operational, and tactical HR support across the employee lifecycle including onboarding, absence management, benefits, HRIS data entry/audits, probation monitoring, payroll onboarding, employee inquiries, and engagement initiatives while partnering with HRBP and other G&A functions.

Lead a CMC Regulatory Affairs team to manage global regulatory submission forms supporting investigational product release to clinical trials. Review submission documentation, liaise cross-functionally, identify CMC regulatory issues, develop tracking systems and procedures, create regulatory justifications, deliver presentations, and support training, metrics, and invoice approvals.

Field-based sales role selling immunology/respiratory products to HCPs. Build and maintain customer and KOL relationships, manage accounts and routes, document activities in CRM, run training/events, and report to sales management.

Field-based sales role promoting Gastroenterology & ENT portfolio to healthcare professionals. Build KOL relationships, manage accounts and routes, document activities in CRM, conduct trainings and congress participation, report to sales management, and support hospital customers while prioritizing patient value.

Lead design and execution of chromatography-based protein purification processes, mentor team members, drive technology development, author technical documentation, improve lab operations and data systems, collaborate cross-functionally, and support regulatory/viral clearance activities for scalable and commercial processes.