Teams at Viatris

Manages global CMC regulatory affairs activities across the pharmaceutical development and manufacturing lifecycle. Prepares regulatory strategies, submissions, post-approval variations, renewals, and responses to agency queries. Assesses regulatory risks, tracks commitments and timelines, ensures global compliance, and collaborates with R&D, Quality, and Regulatory teams. Provides technical guidance and mentors colleagues on complex CMC regulatory matters.

Manages pharmaceutical quality systems supporting batch disposition, complaints, deviations, CAPAs, change controls, supplier qualification, quality agreements, product returns, PQRs, SOPs, training systems, risk assessments, self-inspections, and compliance with GMP, GDP, and GxP requirements. The role also coordinates investigations, vendor oversight, quality documentation, KPIs, and implementation of the regional Quality Management System.

Leads global drug delivery device development programs from concept through registration and launch. Manages integrated plans, resources, budgets, risks, schedules, scenario analyses, contracts, and internal and external partners. Provides technical project leadership, monitors critical milestones, resolves conflicts, and supports development decisions while promoting quality management and environmental, health, and safety compliance.