Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Sassari Client: Location: Job Category: Other - EU work permit required: Yes Job Reference: 8160257735766573056337166 Job Views: 1 Posted: 08.05.2025 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 has been entrusted with recruiting a Global Regulatory Affairs Specialist to join a dynamic, 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 the development and execution of Global Regulatory Strategy for the TPP, ensuring alignment of TPP with core product labelling 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 global HA interaction strategies in collaboration with GRT. Develop and manage Health Authority engagement plans for assigned products, including authoring and leading meetings. Communicate and track interactions with relevant HAs. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core global dossiers, and collaborate across GRT. Ensure submission timelines align with program and company goals. Contribute to and review 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 updates to Affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years' 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 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 and work/study experience. Applications lacking the required qualifications will not be fully considered. Consent to data processing according to GDPR is required. The research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-sassari, IT

Posted Date: 5/11/2025