Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Ferrara col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337133 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 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 work environment. Purpose: The specialist, as a core member of the GRT and strategic partner of the GRL, leverages regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Supports development and execution of Global Regulatory Strategy to support the TPP. Ensures 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 the development of global HA interaction strategies with GRT guidance. Develop and manage HA engagement and interaction plans, including authoring and leading meetings. Maintain accurate communication and tracking with relevant HAs for 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 project and company objectives. 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. Update on project and submission status at GRT meetings. Support GRL updates and interactions with affiliates, 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 management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural/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 with relevant domicile, residence, work experience, or study background. Applications lacking these requirements will not be fully considered. Please provide authorization for personal data processing (DL196/2003, GDPR 679/16). The search is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: ferrara, IT

Posted Date: 5/11/2025