International Regulatory Affairs Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hw3vd

Experteer OverviewIn this role you drive global regulatory strategy to obtain and maintain marketing authorizations for rare disease-focused products. Aumenti le sue possibilità di arrivare alla fase del colloquio leggendo la descrizione completa del lavoro e candidandosi tempestivamente. You will collaborate with international Health Authorities, subsidiaries, and partners to ensure compliance across life‐cycle filings. You shape regulatory documents and guide cross‐functional teams through submissions and lifecycle activities. You will translate complex science into clear regulatory strategies and report outcomes to senior management.Retribuzione / BenefitsLead regulatory strategy, dossier management, and lifecycle activities for pre‐authorization and post‐authorization filings (e.g., ODDs, IMPD, IND, PIP, NDA, MAA; variations, renewals,



annual reports)Provide scientific and regulatory support to international subsidiaries and external partnersMonitor international legislation to keep the portfolio compliant with evolving standardsOversee global filings progress and respond to Health Authority queries; approve labeling mock‐ups with production and partnersManage CROs and external experts delivering regulatory workAct as main contact for internal teams, subsidiaries, and external stakeholders (Health Authorities, Manufacturers, professional bodies)Facilitate internal xrdztoy knowledge sharing on regulatory issues and report to senior managementResponsabilità4 to 5 years in the pharmaceutical industry with proven regulatory affairs experienceExperience in Rare Disease or niche markets preferredProven experience with pre‐approval (IND/IMPD) and post‐approval dossiers (variations/renewals)Strong ability to draft, review, and edit complex scientific and regulatory submissions #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hw3vd