Regulatory Affairs Professional en NOVO NORDISK PHARMA

PMFarma utiliza cookies propias y de terceros para recopilar información con la finalidad de mejorar nuestros servicios y mostrarte publicidad relacionada con tus preferencias. Al continuar navegando por el sitio, aceptas el uso de las mismas. Tienes la posibilidad de configurar tu navegador pudiendo impedir que sean instaladas.   Configurar

Regulatory Affairs Professional

Fecha de la oferta: 13 Mar.
Empresa que publica esta oferta: NOVO NORDISK PHARMA
Somos la compañía líder mundial en el campo del cuidado de la diabetes

Nuestra aspiración es vencer la diabetes encontrando mejores métodos para su prevención, detección y tratamiento.

Trabajamos activamente para promover la colaboración entre todas las partes implicadas en el sistema sanitario con el fin de alcanzar nuestros objetivos comunes.
Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: 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
Tipo de contrato: Indefinido.
Observaciones: We are a Great Place to Work. Come to work with us!

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

Requisitos: 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
Nivel de estudios mínimo requerido: Licenciado
Experiencia profesional mínima requerida: 2 años
Disponibilidad para viajar requerida: El 20% del tiempo laboral

Comparte esta oferta:

Esta oferta ha recibido 79 inscripciones.