Overview 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.
Compensaciones / Beneficios Job stability
comprehensive benefits package
professional development
continuous digital training
versátil working hours
hybrid work model
Responsabilidades Prepare and review product registration dossiers and ensure regulatory compliance for submissions
Coordinate collection and organization of technical documentation to meet regulations




Respond to inquiries and deficiency letters from health authorities and implement required changes
Communicate changes in products or facilities to clients and authorities for transparency
Implement internal policies related to registration processes and provide staff training
Oversee registration activities including updating certificates and issuing permits
Requisitos principales Bachelor in Health Sciences (Pharmacy, Biology or Chemistry)
2 years of experience in a similar role
Proficient level of English
MSc in Pharmaceutical Industry, Regulatory or related field is highly valued
strong communication
attention to detail
proactive problem solving
regulatory affairs
dossier preparation and submission
knowledge of health authority requirements

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