* Leading regulatory team of 2 Regulatory Associates * Management of registration procedures to obtain registrations for generic medicines in line with local legislation * Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases * Translations of SPCs, leaflets and labelling from English to Spanish and vice versa * Reviewing approved product information in post-registration/production phase * Planning coordinating and supervising all activities needed for obtaining marketing authorizations * Communication with local authorities * Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency * Working closely with Regulatory affairs, Pharmacovigilance and QA headquarters and reporting to them We value candidates with:



* University degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, Biology * Minimum 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 Spanish * A 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 #J-18808-Ljbffr

📌 Regulatory Affairs Manager (Madrid)
🏢 Krka
📍 Madrid