Requirements: English
Company: JR Italy
Region: Perugia , Umbria
Social network you want to login/join with:Global Regulatory Affairs Specialist, PerugiaClient:Location:Perugia, ItalyJob Category:Other-EU work permit required:YesJob Reference:8160257735766573056337137Job Views:1Posted:08.05.2025Job Description:Our client, Chiesi Farmaceutici one of the top 50 pharmaceutical companies worldwide, with over 80 years of experience in the pharmaceutical and biotechnology industry, has entrusted IQVIA with recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment.Purpose:As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Support development and execution of global regulatory strategies for the TPP, ensuring alignment with product labelling for development and lifecycle management.Main Responsibilities:Serve as a regional/local regulatory lead and point of contact with Health Authorities.Contribute to the development of global HA interaction strategies in collaboration with GRT.Develop and manage health authority engagement plans, including authoring and leading meetings.Maintain accurate communication and tracking with relevant HAs.Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members.Ensure regulatory submission timelines align with project and company goals.Contribute to content and review of regulated documents.Support operational and compliance activities, including HA contact reports (EU & extra-EU).Assist with GMP, GCP, and GPV inspections.Provide project and submission status updates at GRT meetings.Support 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 biologics.Knowledge of lifecycle management activities (EU and major extra-EU countries).Proficiency with electronic document management systems like Veeva Vault.Ability to handle multiple projects simultaneously.Sensitivity to multicultural and multinational environments.Soft Skills:Stress managementTime managementPlanning and organizational skillsStrategic thinkingWe offer:Competitive salary packagePermanent contractChemical contractIQVIA reserves the right to evaluate candidates based on domicile/residence, work experience, and studies matching the requirements. Applications lacking these requirements will not be fully considered. Please provide authorization for personal data processing (D.L. 196/2003 - GDPR 679/16) for IQVIA and its clients. This research is urgent and open to candidates of all genders (L.903/77).#J-18808-Ljbffr