Social network you want to login/join with: Global Regulatory Affairs Specialist, asti col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337156 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 work in an dynamic, international environment. Purpose: As a core member of the GRT and a strategic partner of the GRL, leverage your regulatory expertise to contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Support the development and execution of Global Regulatory Strategy for the TPP, ensuring alignment of TPP with 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 global HA interaction strategies in collaboration with GRT. Develop and manage Health Authority engagement and interaction 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 global 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 HA contact reports (EU & EXTRA-EU). Assist with GMP, GCP, and GPV inspections. Provide project and submission 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: Details not specified. Languages: Details not specified. Technical Skills: Understanding of clinical development of drugs and biologics. Knowledge of lifecycle management activities in EU and major extra-EU countries. Experience with electronic document management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural and 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, work experience, and studies. Applications lacking required qualifications will not be fully considered. Please authorize the processing of personal data in accordance with GDPR. The search is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr