Global Regulatory Affairs Specialist

Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience in the pharmaceutical and biotechnology industry – has entrusted IQVIA with the recruitment of a Global Regulatory Affairs Specialist to expand their staff. This role offers an exciting working environment in a dynamic and international atmosphere. Purpose: As a core member of the GRT and a strategic partner of the GRL, leverage regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly within and across regions to ensure the delivery of business objectives. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with Health Authorities. Contribute to the development of global HA interaction strategies in collaboration with GRT. Develop and execute Health Authority engagement and interaction plans for assigned products, including authoring and leading meetings. Ensure accurate communication and tracking with relevant HAs for projects/products. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core global dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. Contribute to content and review of regulated documents. Support operational and compliance activities, including HA contact reports (EU & EXTRA-EU). Support GMP, GCP, and GPV inspections from health authorities. Provide updates on project and submission statuses at GRT meetings. Assist the GRL with updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years of experience in Regulatory Affairs. Education: Languages: Technical Skills: Understanding of clinical development of drugs and/or biologics products. Knowledge of Lifecycle Management activities (strategy and execution in EU and major extra-EU countries). Ability to work with electronic document management systems, such as Veeva Vault. Proven ability to handle multiple projects simultaneously. Sensitivity to multicultural/multinational environments. Soft Skills: Stress management Time management Planning and organizational skills Strategic thinking We offer: Competitive salary package Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates based on domicile/residence and work/study experience that meet the requirements. Applications without the specified requirements will not be fully considered. Please provide authorization for data processing in accordance with GDPR (Regulation 679/16). This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: vicenza, IT

Posted Date: 6/17/2025