pul liLeading regulatory team of 2 Regulatory Associates /li liManagement of registration procedures to obtain registrations for generic medicines in line with local legislation /li liMaintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases /li liTranslations of SPCs, leaflets and labelling from English to Spanish and vice versa /li liReviewing approved product information in post-registration/production phase /li liPlanning coordinating and supervising all activities needed for obtaining marketing authorizations /li liCommunication with local authorities /li liMonitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency /li liWorking closely with Regulatory affairs,



Pharmacovigilance and QA headquarters and reporting to them /li /ul pbWe value candidates with: /b /p ul liUniversity degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, Biology /li liMinimum 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) /li liFluent English and Spanish /li liA 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 communication /li /ul /p #J-18808-Ljbffr

📌 Regulatory Affairs Manager (Madrid)
🏢 Krka
📍 Madrid