Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Ancona col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337131 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 seeking to expand their team. IQVIA has been entrusted with recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose: As a core member of the GRT and a strategic partner of the GRL, leverage regulatory expertise to contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies. Work flexibly across regions to ensure business objectives are met. Support development and execution of Global Regulatory Strategy to support the TPP, and ensure alignment of TPP with core product labelling for development and lifecycle management in assigned regions. Main Responsibilities: Serve as regional/local regulatory lead and point of contact internally and with Health Authorities. Contribute to developing global HA interaction strategies with GRT guidance. Develop and manage Health Authority engagement and interaction plans, including authoring and leading meetings. Maintain accurate communication and tracking with relevant HAs for assigned projects/products. 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. Contribute to content and review of regulated documents. Support operational and compliance activities, including HA contact reports (EU & EXTRA-EU). Support GMP, GCP, and GPV inspections from health authorities. Provide updates on project and submission status 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: Not specified. Languages: Not specified. Technical Skills: Understanding of clinical development of drugs and biologics. Knowledge of Lifecycle Management activities in EU and major extra-EU countries. Ability to work with electronic document management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Strong sensitivity to multicultural/multinational environments. Soft Skills: Stress management Time management Planning and organizational skills Strategic thinking What We Offer: Competitive salary package Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates based on domicile/residence, work experience, and studies aligning with the requirements. Applications lacking these requirements will not be fully considered. Please provide consent for personal data processing in accordance with GDPR (L.903/77, 13 GDPR 679/16). This research is urgent and open to candidates of all genders. J-18808-Ljbffr

Location: provincia-di-ancona, IT

Posted Date: 5/12/2025