Global Regulatory Affairs Specialist

Global Regulatory Affairs Specialist, Cuneo Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337128 Job Views: 1 Posted: 08.05.2025 Expiry Date: 22.06.2025 Job Description: Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies worldwide with over 80 years of experience in the pharmaceutical and biotech industries – is expanding its team. IQVIA is 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 Strategies to support the TPP and ensure alignment of TPP with core product labelling for development and lifecycle management. Main Responsibilities: Serve as a 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. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop global dossiers, and collaborate with GRT members. Ensure submission timelines align with program and company goals. Contribute to and review regulated documents. Support operational and compliance activities for deliverables and HA contact reports (EU & extra-EU). Assist with GMP, GCP, and GPV inspections. Provide updates on project and submission statuses at GRT meetings. Support GRL with updates to Affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years' experience in Regulatory Affairs. Education: Relevant educational background. Languages: Proficiency in required languages. Technical Skills: Understanding of clinical development and biologics products. Knowledge of LCM activities in EU and major extra-EU countries. Experience with electronic document management systems like Veeva Vault. Ability to manage multiple projects simultaneously. Sensitivity to multicultural/multinational environments. Soft Skills: Stress and 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 education aligning with the requirements. Applications lacking these requirements will not be fully considered. Please provide consent for data processing under GDPR (Regulation 679/16). This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-cuneo, IT

Posted Date: 5/24/2025