Lonza Biologics Porriño site is a commercial/late phase clinical mammalian manufacturing site. The Site Regulatory Affairs CMC Manager will be responsible to handle and facilitate on-site regulatory CMC related product specific activities. This will entail to ensure site products/programs adherence to regulatory requirements (for clinical, commercial approval and product life cycle maintenance). In alignment with Lonza Site Quality and Customer Regulatory, the position will ensure effective regulatory support to process transfers, change requests and deviations, ensuring site product specific regulatory compliance and submission readiness. This includes dossier preparation (writing and or review of clinical, commercial and product life cycle maintenance customer submissions).