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Maximice sus posibilidades de que su candidatura sea seleccionada asegurándose de que su CV y sus habilidades se ajustan al perfil.

- 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:

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- 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, xcskxlj 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