Global Regulatory Affairs Specialist

Job Description: Global Regulatory Affairs Specialist, Lodi 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 – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment. Purpose: As a core member of the GRT and strategic partner of the GRL, you will leverage your regulatory expertise to contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies. You will work flexibly across regions to ensure business objectives are met and support the development and execution of global regulatory strategies for the TPP, ensuring alignment with product labeling for development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with health authorities. Contribute to the development of global health authority interaction strategies in collaboration with GRT. Develop and manage health authority engagement and interaction plans for assigned products, including authoring and leading meetings. Maintain accurate communication and tracking with relevant health authorities. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. Review and contribute to regulated documents. Support operational and compliance activities, including health authority contact reports (EU & extra-EU). Assist with GMP, GCP, and GPV inspections. Provide project and submission updates at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience and Education: Approximately 3 years of experience in Regulatory Affairs. Specific educational requirements are not detailed but should align with industry standards. Technical Skills: Understanding of clinical development, biologics, and lifecycle management activities in EU and major extra-EU countries. Experience with electronic document management systems like Veeva Vault. Ability to manage multiple projects simultaneously. Multicultural/multinational environment sensitivity. Soft Skills: Stress and 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, work experience, and studies. Applications lacking these requirements may not be fully considered. Please provide authorization for data processing as per GDPR. The position is open to candidates of all genders. J-18808-Ljbffr

Location: provincia-di-lodi, IT

Posted Date: 6/16/2025