Social network you want to login/join with: Global Regulatory Affairs Specialist, Frosinone col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337162 Job Views: 1 Posted: 08.05.2025 Expiry Date: 22.06.2025 col-wide Job 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, 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, 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 Strategy to support the TPP. Ensure alignment of TPP to core product labelling for development and lifecycle management in assigned regions. Main Responsibilities: Serve as regional/local regulatory lead and contact point internally and with Health Authorities. Contribute to the development of global HA interaction strategies with GRT guidance. Develop and manage Health Authority engagement and interaction plans, including authoring and leading meetings. Communicate and track interactions with relevant HAs for assigned projects/products. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop global dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company goals. Review and contribute to regulated documents. Support operational and compliance activities for deliverables and HA reports (EU & EXTRA-EU). Assist with GMP, GCP, and GPV inspections. Provide project and submission updates 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: Details not specified. Languages: Details not specified. Technical Skills: Understanding of clinical development and biologics products. Knowledge of lifecycle management activities in EU and major extra-EU countries. Experience with electronic document systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural/multinational environments. Soft Skills: Stress management Time management Planning and organization Strategic thinking We offer: Competitive salary Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates with domicile/residence and work/study experience matching the requirements. Applications without the specified requirements will not be fully considered. Please authorize the processing of personal data as per GDPR (Regulation 679/16). This research is urgent and open to candidates of both sexes (L.903/77). J-18808-Ljbffr