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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.

Lead regulatory strategy and compliance for medical devices and drug-device combination products globally. Serve as SME on FDA, EU MDR and ISO standards, guide program teams on regulatory plans and submissions (NDA/ANDA/BLA/MAA), mentor the regulatory team, and support SaMD classification and global IT compliance.

The Senior QC Analyst will analyze raw materials and products, review analytical data, conduct method validations, and provide training while ensuring compliance with regulations.

The QC Analyst - Micro role involves analyzing raw materials and products, monitoring manufacturing areas, and performing method validations while adhering to GMP standards.

The Director Respiratory Regulatory CMC leads regulatory strategies for respiratory products, managing stakeholder relationships, CMC submissions, and compliance with regulatory agencies to support product development and lifecycle management.

Drive order fulfillment and transactional activity across the supply network using SAP/ERP: create and manage POs, SOs, inbound/outbound deliveries, invoices, reporting, KPI analysis, process documentation, stakeholder liaison, and reporting for supply chain operations.

The Operational Excellence Lead drives transformational change, champions Lean Six Sigma, mentors teams, and implements sustainable process improvements to enhance quality and efficiency.

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

The Senior Manager, Core Labelling Strategy leads regulatory labelling governance for Viatris, ensuring compliance and strategic direction in labelling documentation and processes for pharmaceutical products.

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.