Jobs 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.

Manage and publish regulatory dossiers for product submissions, ensuring compliance and quality control while mentoring junior staff. Act as a subject matter expert for publishing activities.

Two-year graduate programme with three structured rotations across pharmaceutical departments including production, engineering, automation, quality, EHS, supply chain, regulatory affairs, and operational excellence. Participants complete impactful projects, receive mentorship and training, develop technical and business skills, and gain exposure to pharmaceutical operations and technology. The programme is based at Viatris sites or its global Dublin office and is intended for high-achieving STEM graduates interested in building careers in the pharmaceutical industry.

Lead risk management for medical devices and combination products across the product lifecycle. Develop and maintain Risk Management Files, perform FMEA/FTA/Medical Hazard Analyses, support regulatory submissions, assess post-market data, and drive RM process improvements while collaborating with Quality, Clinical, and Pharmacovigilance stakeholders.

The Senior Specialist will oversee global regulatory operations, ensuring compliance with EU regulations, managing data governance, and leading process improvements within regulatory initiatives.

The Director of Regulatory Compliance will establish and lead the Global Regulatory Affairs Compliance function, ensuring adherence to regulatory processes, managing audits, and evolving the Quality Management System while collaborating with cross-functional teams.

Prepare and submit marketing authorisation dossiers and post-approval changes for EU territories, maintain regulatory databases and SPPs, develop regulatory strategies, support due diligence, liaise with internal teams and 3rd parties, mentor junior staff, and ensure compliance with health authority requirements and company SOPs.

Lead a Human Factors/User Interface team for medical devices and drug-device combination products. Translate user needs into design inputs, oversee formative and summative HF studies (including comparative use), ensure regulatory compliance and risk management, standardize documentation, manage vendors, collaborate cross-functionally, and mentor staff to deliver inspection-ready usability evidence supporting development and submissions.

The Director Regulatory CMC Sciences manages complex global regulatory projects involving site transfers and API sourcing, ensuring effective collaboration and compliance across teams while mitigating regulatory risks.

The role involves leading regulatory project management for complex manufacturing changes, ensuring compliance, and collaborating with internal stakeholders to optimize processes.

Two-year graduate programme launching September 2025 with three structured rotations across pharmaceutical site departments (e.g., Production, Automation, Engineering, EHS, Quality, Supply Chain, Regulatory Affairs, OpEx). Participants work on impactful projects, receive mentorship and training, attend career and STEM events, and gain practical pharmaceutical operations experience with clear career progression opportunities.

Two-year graduate development programme with three structured rotations across pharmaceutical site departments (e.g., Production, Engineering, Quality, Supply Chain). Participants work on impactful projects, gain hands-on operational experience, receive mentorship and training, attend career and outreach events, and follow a clear pathway for career progression within the company.

As the Global Regulatory Business Process Lead, you will optimize regulatory processes, ensure adherence to compliance, and utilize data analytics for continuous improvement. You'll collaborate cross-functionally and lead training initiatives.

The Senior Manager, Global Device Quality leads quality system improvements ensuring compliance with global medical device regulations, collaborates on corporate quality initiatives, and interacts with regulatory authorities while managing compliance and audit activities.

The Director of Regulatory Affairs CMC is responsible for strategic CMC regulatory approaches and managing relationships with stakeholders to ensure compliance and efficiency in regulatory submissions.

The Senior Manager, Regulatory Affairs manages global regulatory compliance, prepares submissions, leads CMC activities, collaborates with teams, and mentors colleagues.

Oversee Design Assurance for medical devices, manage technical documentation, and support manufacturing transfer while ensuring compliance with regulations.

The Planning Master Data Analyst manages planning master data across SAP and advanced systems, ensuring data quality and collaboration across global supply chain teams, particularly during the SAP S/4HANA transformation process.