It-regulatory Affairs Department Internship

4 giorni fa

Roma, Italia Daiichi Sankyo Europe A tempo pieno

**Passione per l'innovazione. Considerazione per i pazienti.**:
Con oltre 120 anni di esperienza scientifica e più di 17.000 dipendenti in oltre 20 Paesi, Daiichi Sankyo è attivamente impegnata nello scoperta, sviluppo diffusione di nuovi standard di cura che arricchiscono la qualità della vita in tutto il mondo.

In Europa ci concentriamo su due aree: l'obiettivo della divisione Specialty Business è proteggere le persone dalle malattie cardiovascolari, la principale causa di mortalità in Europa, e aiutare i pazienti che ne soffrono a godere di ogni prezioso momento della vita. In Oncologia, vogliamo diventare una global pharma innovator con un forte vantaggio competitivo, creando nuove opzioni terapeutiche per le persone affette da patologie oncologiche.

Il nostro headquarter europeo si trova a Monaco, in Germania, e abbiamo filiali in 13 Paesi europei e in Canada.

IT-Regulatory Affairs Department Internship

Daiichi Sankyo Italy, Milan

**THE POSITION**:
**ROLE AND RESPONSIBILITIES**:
- Regulatory activities related to the European registration process and the launch in Italy of new medicines or new therapeutic indications.
- Lifecycle management activities for already approved Daiichi Sankyo medicines.
- Management of product information and packaging materials (artworks) for Daiichi Sankyo medicines, ensuring compliance with current regulations.
- Activities for the implementation of serialization in Italy.
- Activities related to early market access for medicines, including compassionate use and Cnn.
- Preparation of price and reimbursement dossiers in synergy with market access and medical affairs functions, following the local access strategy.
- Review and submission to AIFA of promotional materials intended for healthcare professionals, ensuring compliance with national legislation and company procedures.
- Review of non-promotional materials, including, for example, those used by the medical and market access departments, press releases, etc., ensuring compliance with national legislation and company procedures.
- Daily monitoring of national and international websites to identify new/updated European and national regulatory legislation and to gather relevant information on Daiichi Sankyo medicines and the competitive landscape.

**QUALIFICATIONS & REQUIREMENTS**:
- Degree in scientific disciplines (preferably Chemistry and Pharmaceutical Technologies, Pharmacy, Biology, or similar).
- Excellent command of written and spoken English.
- A second-level Master's degree in Regulatory Affairs or related disciplines is considered a plus but is not mandatory.
- Ability to collaborate and interact with different business functions.
- Organizational and time management skills.
- Sense of responsibility, reliability, and integrity in completing assigned tasks.
- Aptitude for innovation and creative thinking.

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