« Torna ai risultati Regulatory Affairs Specialist Categoria professionale Scientifico / Farmaceutico - Regulatory affairs specialist Località Milano, Milano Data inizio 30/09/2022 Job reference 0660-4187 Riferimento esterno REGULATORYAFFAIRSSPECIALIST-0660-4187 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). Lingue conosciute:IngleseDisponibilità oraria: Full TimePatente: BResponsabilità:Contract: Ccnl Chimico Farmaceutico (12 month contract)Send their curriculum vitae (word format), with authorization to process personal data to email@example.com & firstname.lastname@example.org The candidates that don't meet with the requirements and the applications without an attached CV will not be considered. MoreInformation × QA.Fillout.Fields Regulatory Affairs Specialist Milano , Milano - QA.First.Name* QA.FirstName.Required QA.Last.Name* QA.Lastname.Required QA.Phone* QA.Phone.Required QA.TermsCheckbox QA.Terms.Required QA.Checkbox QA.Email* QA.Email.Required QA.Zipcode* QA.Zip.Required QA.WorkExperience QA.JobTitle QA.JobTitle.Required QA.JobDuties QA.JobDuties.Required QA.Recaptcha.Failed QA.Employment.Eligibility QA.Equal.Opportunity QA.Qualified.Applicants MO.Close.QuickApply × × QA.Application.Submitted QA.Thank.Apply QA.Keep.Track Condividi questa pagina su 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). Facsimile di domanda è disponibile al seguente link Facsimile domanda candidatura. ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa al seguente link . Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).