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Detalle de la oferta

Datos de empresa

Oferta de empleo

Regulatory Affairs Professional (Temporary)
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:

- Marketing authorisations and variations of medicinal products (especilly Centralised Procedure) and medical devices in order to ensure timely approvals
- Special use of medicinal products (“Compassionate Use” and “Foreign Drugs”)
- Communication, sharing documentation and supporting partners
- Handling the creation, approval and update of packaging materials
- Updating internal databases and systems
- Ensuring compliance with Good Distribution Practices
- Supporting quality complaints, counterfeit issues and potential recalls
- Following, analysing and implementing national regulatory legislations & informing HQ accordingly
- Following and analysing the Competitors regulatory information & informing internally accordingly
- Supporting other RA tasks (free samples, repackaging, supporting in tenders, annual marketing statement…)
- Supporting with planning and follow-up on regulatory work for Spain
- Handling external technical inquires
- Keeping Clinical Operations informed on comparators information
- Review, approval and communication to local HA of Promotional Materials. Provide support regarding local requirements.
- Responsible Technician (Local Qualified Person) Back-up
- Work according to Business Ethics, local law, NN Way and NN policies & guidelines

Requisitos del candidato

Inglés (Alto)
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 Regulatory Affairs experience

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