Adecco Life Science Italia is looking for a:
Regulatory Affairs Specialist
(12 month contract)
A major Multinational Pharmaceutical Company is looking for a Regulatory Affairs Specialist based in Milan.
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 company policies and local regulatory requirements.
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 pharmaceutical company 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;
• Managing translations in Italian of text documents (SmPC, package leaflet. labelling);
• Manage packaging changes for Pharma Italy marketed products;
• 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;
• Collaboration with local Pharmacovigilance, Quality Assurance, Marketing and Medical departments;
• Collaboration with International Regulatory Affairs Team.
Education
• 1/2 years 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).
Contract: Ccnl Chimico Farmaceutico (12 month contract)
Send their curriculum vitae (word format), with authorization to process personal data to francesca.pagano@adecco.it & giovannicarmelo.viola@adecco.it The candidates that don't meet with the requirements and the applications without an attached CV will not be considered.
Categoria Professionale: Scientifico / Farmaceutico
Città: Milano (Milano)
Conoscenze linguistiche:
- Inglese
Patenti:
- B
Disponibilità oraria:
- Full Time
