Key Responsibilities:Leading regulatory team of 2 Regulatory AssociatesManagement of registration procedures to obtain registrations for generic medicines in line with local legislationMaintenance of existing registrations (variations, renewals), maintenance of regulatory data-basesTranslations of SPCs, leaflets and labelling from English to Spanish and vice versaReviewing approved product information in post-registration/production phasePlanning coordinating and supervising all activities needed for obtaining marketing authorizationsCommunication with local authoritiesMonitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agencyWorking closely with Regulatory affairs,



Pharmacovigilance and QA headquarters and reporting to themPlanning coordinating and supervising all activities needed for obtaining marketing authorizationsCommunication with local authoritiesWe value candidates with:University degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, BiologyMinimum 3 years of experience in registrations (knowledge of local and international regulatory procedures and relevant legislation, knowledge of price and reimbursement procedure, working with local authorities, some experiences in pharmacovigilance)Fluent English and SpanishA person who is team oriented, accurate and good with details, self-initiative, organized and efficient, able to meet deadlines and has an honest, transparent attitude and communicationPlease attach your

📌 Regulatory Affairs Manager (Madrid)
🏢 Krka
📍 Madrid