Requirements: English
Company: IQVIA Italia
Region: italia ,
Our client, Chiesi Farmaceutici one of the top 50 pharmaceutical companies in the world, 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 a strategic partner of the GRL, leverages regulatory expertise to contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies. Works flexibly across regions to ensure the achievement of business objectives.Supports the development and execution of Global Regulatory Strategy to support the TPP.Ensures alignment of TPP with core product labeling for development and lifecycle management within assigned regions.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, independently or with GRL guidance.Develop and manage Health Authority engagement and interaction plans for assigned products, 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 program and company goals.Contribute to the 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 updates on project and submission statuses at GRT meetings.Support 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 processes and biologics.Knowledge of Lifecycle Management activities in EU and major extra-EU countries.Proficiency with electronic document management systems like Veeva Vault.Ability to manage 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 aligning with the requirements. Applications lacking these requirements will not be fully considered. Candidates must provide authorization for data processing in accordance with GDPR (Regulation 679/16). This urgent recruitment is open to candidates of all genders (L.903/77).#J-18808-Ljbffr