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