Regulatory Affairs Specialist

  • Categoria professionale
    Scientifico / Farmaceutico - Regulatory affairs specialist
  • Settore
    INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
  • Località
    Milano, Milano
  • Data inizio
  • Job reference
    0739-2055
  • Riferimento esterno
    REGULATORYAFFAIRSSPECIALIST-0739-2055

The RA Specialist works under the responsibility of the Regulatory Affairs Manager Italy. He/she will provide support to the local regulatory activities managed by the Regulatory Affairs Manager Italy in accordance with Alexion policies and local regulatory requirements. The position is based in Milan.

Principal Activities
• Review and submit to AIFA promotional and non-promotional materials in accordance with the Pharmaceutical Lawn. 219/2006
• Submission to AIFA for approval of Congresses' sponsorship
• Periodic communications to Regions and AIFA on Numbers of HCP visited by RAM
• Management and local implementation of Risk Management Plan (education materials, certificate of vaccinations)
• Managing translations in Italian of text documents (SmPC, package leaflet. labelling)
• Manage packaging changes for Alexion Pharma Italy marketed products
• Monitor regulatory/pharmaceutical regulations (Regulatory intelligence)
• Partner with local pharmacovigilance department in implementing the risk minimization measures
• Drafting and updating SOPs under regulatory responsibility
Education
• 2-3 year experience in pharmaceuticals industry in regulatory affairs
• Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
• Master in Regulatory Affairs will be a plus

Skills
• Ability to work independently
• Ability to build team relationship and collaborate in a global team environment at all level of the organization.
• Good interpersonal communication and organizational skills.
• Fluent in English oral and written communication.
• Ability to work in a flexible environment to meet all regulatory requirements and business requirements
• Good Computer skills (Excel, Word, Power Point)


Disponibilità oraria: Full Time

CCNL: Chimico Farmaceutico



I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l’informativa sulla privacy (Regolamento UE n. 2016/679). 

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