- 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