In this role you support the pharmaceutical manufacturer by preparing and reviewing regulatory dossiers, ensuring compliance, and coordinating documentation for health authority submissions. You will liaise with authorities and clients on changes to manufacturing or control processes, and help implement and train staff on regulatory policies. You will oversee ongoing registration activities, including certificates and permits, contributing to a compliant, transparent operation.



This role offers professional development in a high-quality pharmaceutical environment and a hybrid work setup.Job stabilityPrepare and review product registration dossiers and ensure regulatory compliance for submissionsCoordinate collection and organization of technical documentation to meet regulationsRespond to inquiries and deficiency letters from health authorities and implement required changesCommunicate changes in products or facilities to clients and authorities for transparencyImplement internal policies related to registration processes and provide staff trainingOversee registration activities including updating certificates and issuing permitsBachelor in Health Sciences (Pharmacy, Biology or Chemistry)2 years of experience in a similar roleProficient level of EnglishMSc in Pharmaceutical Industry, Regulatory or related field is highly valuedstrong communicationproactive problem solvingregulatory affairsdossier preparation and submissionknowledge of health authority requirements#J-18808-Ljbffr

📌 Regulatory Affairs - Marlex Human Capital (Barcelona)
🏢 Marlex Human Capital
📍 Barcelona