- 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
- Planning coordinating and supervising all activities needed for obtaining marketing authorizations
- Communication with local authorities
- 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 xqbhyrx 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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Como Public Affairs Senior Manager contribuirás a la definición de la estrategia de asuntos públicos y liderar la implementación de iniciativas de Public Affairs en España. · Experiencia mínima de 8–10 años en Public Affairs, relaciones institucionales o asuntos regulatorios. · ...
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Leading regulatory team of 2 Regulatory Associates and management of registration procedures to obtain registrations for generic medicines in line with local legislation. · ...
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Regulatory Affairs Manager - Madrid - Krka
Descripción
Key Responsibilities:
La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.We value candidates with:
Please attach your CV in English till 15 March 2026.
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Public Affairs Senior Manager
Solo para miembros registrados Madrid
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Public Affairs Senior Manager
Solo para miembros registrados Madrid, Community of Madrid
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Pharmaceutical Affairs Manager
Solo para miembros registrados Madrid
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Regulatory Affairs Manager
Solo para miembros registrados Madrid
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Pharmaceutical Affairs Manager
Solo para miembros registrados Madrid, Community of Madrid
-
Regulatory Affairs Manager
Solo para miembros registrados Madrid
-
Regulatory Affairs Manager
Solo para miembros registrados Madrid, Community of Madrid
-
Legal Affairs Manager
Solo para miembros registrados Madrid
-
Regulatory Affairs Manager
Solo para miembros registrados Spain
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Legal Affairs Manager
Solo para miembros registrados Madrid, Community of Madrid
-
Regulatory Affairs Manager
Solo para miembros registrados Madrid, Community of Madrid
-
Public Affairs Manager Spain
De jornada completa Solo para miembros registrados Madrid
-
Regulatory Affairs Project Manager – Plant Protection
Solo para miembros registrados Madrid
-
Regulatory Affairs Project Manager – Plant Protection
Solo para miembros registrados Madrid, Community of Madrid
-
Regulatory Affairs Project Manager – Plant Protection
Solo para miembros registrados Madrid, Madrid provincia
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Regulatory Affairs Manager Health and Wellness Supplements
Solo para miembros registrados Spain
-
Scientific Affairs Specialist
Solo para miembros registrados Madrid
-
Senior Regulatory Affairs Specialist
Solo para miembros registrados Madrid
-
EMEA Senior Medical Advisor/Medical Education Lead Cardiovascular
De jornada completa Solo para miembros registrados Madrid
-
Administration Specialist
Solo para miembros registrados Madrid
-
Cluster Medical Lead
Solo para miembros registrados Madrid