Main Purpose To support product lifecycle management through to the generation and maintenance of commercially valuable product licences for Novo Nordisk in Spain
Key Accountabilities REGULATORY Handling Marketing authorisations, variations and packaging materials of all our medicinal products & devices. Following-up of submissions with the AEMPS to ensure timely approvals. Supporting the maintenance of the Regulatory licences of NN Pharma and its facilities. Handling Regulatory Affairs activities in launches and discontinuations. Following, analyzing and implementing the competitors and the national regulatory legislation & informing internally accordingly. Supporting other Regulatory Affairs tasks (free samples, repackaging, foreign medication, annual marketing statement…) and Supporting in tenders. Providing accurate and relevant internal regulatory advice. Communication of the Annual report for the medical promotional activities to our local Health Authorities. Review, approval and communication to local Health Authorities of Promotional Materials and provide support regarding local requirements. Quarterly communication of Sales Representatives promotional visits from to local Health Authorities. Continuously implementing improved and simplified Regualtory Affairs internal procedures.
TECHNICAL RESPONSIBLE Ensuring compliance with Good Distribution Practices (supervising release of product and handling temperature deviations) and SIGRE an NO SIGRE commitments. Supporting quality complaints, counterfeit issues and potential recalls.
SAFETY Back-up for Safety tasks
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At Novo Nordisk, we use our skills, dedication and ambition to help people with chronic diseases. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
Requisitos del candidato
De 1 a 3 años
Knowledge & Experience.
• Life-Sciences Degree • High fluency in Spanish and English, both written and spoken • At least 2 years of experience in a Regulatory Affairs role • Desirable: Experience in Safety and Quality