Jobs at Lavipharm S.A.

The Officer Regulatory Affairs will ensure compliance of marketed products, prepare regulatory dossiers, manage submission timelines, and update packaging materials.

Plan and execute financial, operational, compliance, and risk-based audits; evaluate governance and internal controls; identify control gaps and recommend corrective actions; prepare audit reports; support fraud and regulatory reviews; and use data analytics and ERP tools to improve audit quality.

Prepare and maintain CMC regulatory dossiers (CTD Module 3 and Module 2.3), ensure compliance with relevant regulations, implement RA policies, maintain regulatory databases and filing systems, coordinate with R&D/Quality/Operations, and provide CMC regulatory support across departments.

Procure materials, products, and services at optimal cost and quality. Manage supplier relationships, negotiate terms, conduct market research, support R&D sourcing, schedule deliveries, monitor supplier performance, maintain supplier databases, and propose ERP improvements.

Oversee production planning and scheduling for pharmaceutical manufacturing, ensuring efficient resource allocation, regulatory compliance, inventory control, KPI tracking, and team leadership to meet production, quality, and delivery targets.

Oversee daily credit operations, assess customer creditworthiness, maintain credit files, monitor accounts receivable and collections, resolve billing disputes, generate reports on credit risk, and recommend process improvements.

The Accountant will support accounting operations, ensure compliance with tax regulations, assist in financial reporting, and maintain internal controls.

Lead and manage the Quality Operations team to execute GMP-compliant QA activities on the manufacturing floor. Oversee batch release, investigations (deviations, OOS/OOT, complaints), CAPA, change control, recalls, product quality reviews, and cross-functional quality interfaces. Ensure regulatory compliance (EudraLex, ICH Q8/Q9/Q10) and continuous improvement of eQMS/eDMS processes.

Act as the Qualified Person (QP) responsible for personal, non-delegable batch certification under Directive 2001/83/EC and Annex 16. Independently verify GMP compliance, analytical results, deviations, change controls, labelling, documentation, and narcotics controls for multi-market releases. Interface with regulators and MAH partners, support inspections and recalls, and ensure right-first-time documentation and risk-based release decisions across MAH and CMO scenarios.

Responsible for regulatory support across the product life cycle, ensuring compliance with regulations, maintaining documentation, and interacting with regulatory authorities.