Guardar Back to Search Descripción Resumen Ofertas similares Actualizado el 04/06/2025Generic Drugs (inyectable, solid, semi-solid)Barcelona or Madrid based (100% remote)¿Dónde vas a trabajar?European Pharmaceutical Company.DescripciónRegistration of generic medicinal products already approved by SRA (EU, MHRA, Canada etc) in accordance with national regulations of the Brazil, Mexico, Columbia, Chile, Costa Rica, Argentina, Peru, UruguayCommunication with state authorities and/or local agents during the registration process.Supervision and maintenance of up-to-date registration documentation in the post-registration period: variations, renewals.Responsibility for the transfer of registration (MAH transfer) within implementation timelines.Close cooperation with Headquarter company management.Coordinate where applicable the translations for SmPC, product labelling, artwork and patient information.Keep records and files of Regulatory activities and databases.Monitoring changes in legislation and regulations and ensuring their implementation in the companyIn charge of the EU dossiers that will pass to LATAM, focused on modul 1 and 2 (module 3 / CMC will come from EU sites)Main requirement for the candidate is the competency and knowledge to adapt EU dossier for LATAM countries.Be able to answer questions about the module 3 documents adaption, programs and platforms used for adapting EU dossiers to LATAM standards.¿A quién buscamos (H/M/D)?University Degree in science, preferably in chemistry, pharmaceutical technology or pharmacyMinimum 5 years experience RA Generics for LATAM regionIn-depth understanding of regional and global regulatory requirements for pharmaceuticals.Strong analytical and problem-solving skills.Responsible and independentExcellent communication and interpersonal skills.Ability to work effectively in a team environment.Exceptional attention to detail and organisational skills.Ability to manage multiple projects and deadlines in a fast-paced environment.Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).Advanced English level and Spanish native¿Cuáles son tus beneficios?Remote / Home Office 100% (Barcelona or Madrid based)Unique opportunity to join the company in very exciting phase of business growth.Extensive motivation program.Dynamic work environment.Career development opportunities, professional as well as personal growth.Ver más ofertas de empleoCristian AtikIndicar número de referencia para la ofertaJN-042025-6727776Resumen de empleoSectorHealthcareSub SectorRegistrosIndustriaHealthcare / PharmaceuticalLocalizaciónMadridTipo de ContractoPermanentNombre del consultorCristian AtikNúmero de referenciaJN-042025-6727776Modalidad de trabajoRemoto / híbrido
