Jobs at Viatris

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.

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.

Support generation and maintenance of purchase specifications, documentation, timelines, defect reports and QMS actions; collaborate with stakeholders and functional teams to support packaging, labelling and wider device development program deliverables.

Manage timely execution of orders to maximize revenue, resolve order blocks, produce supply chain KPI reporting, create inbound delivery and PGI in SAP, support product launches and divestitures, lead ad-hoc project delivery and process documentation, maintain SAP data integrity, and design reporting and process improvements.

Own global governance of supply chain flows for Viatris products, mapping end-to-end product and financial flows, managing a central repository, coordinating cross-functional stakeholders, supporting IT integrations (SAP, RapidResponse), driving network optimization projects, and delivering training and documentation.

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.

The Senior Manager will oversee European regulatory policies, lead intelligence reports, and ensure strategic engagement with health authorities, providing actionable insights for regulatory compliance.

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 development programme with three rotations across pharmaceutical site departments (Production, Automation, Engineering, EHS, Quality, Supply Chain, Regulatory Affairs, OpEx). Participants work on impactful projects, receive mentorship and training, gain technical and business skills, and attend career and STEM outreach events. Locations across multiple Irish sites with career progression opportunities within Viatris.

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.

Lead regulatory strategy and execution for medical devices and drug-device combination products. Author and review regulatory submission content (NDA, ANDA, BLA, MAA, NBOp), guide Device Program Teams on compliance with FDA, EU MDR, ISO standards, and design controls, and support team development and cross-functional collaboration to align regulatory plans with program timelines.

Lead development and validation of test methods for combination products, provide lab technical expertise and mentorship, oversee testing at external facilities, perform statistical analysis and trending, compile technical and regulatory documentation, support investigations and R&D lab activities, and ensure compliance with regulatory and EHS requirements.

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.

Lead end-to-end technical program management for global drug-delivery device development from concept through registration and launch. Own project plans, resource forecasts, risk registers, budgets and contracts; drive cross-functional partner alignment, scenario analyses, risk management, and timely reporting while promoting QMS and EHS compliance.

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.