Jobs at Viatris

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.