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

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📌 Regulatory Affairs Manager (Madrid)
🏢 Krka
📍 Madrid