Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Arezzo col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337136 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 industries – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose: The specialist acts as a core member of the GRT and a strategic partner of the GRL, leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies. They work flexibly across regions to ensure business objectives are met and support the development and execution of global regulatory strategies to support the TPP. They also ensure alignment of TPP with core product labeling for development and lifecycle management within assigned regions. Main Responsibilities: Serve as a regional/local regulatory lead and contact point internally and with health authorities. Contribute to developing global health authority 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 health authorities. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core global dossiers, and collaborate across GRT members. Align regulatory submission timelines with project and company objectives. Contribute to the content and review of regulated documents. Support operational and compliance activities, including health authority contact reports (EU & extra-EU). Support GMP, GCP, and GPV inspections by health authorities. Provide updates on project and submission statuses at GRT meetings. Support the 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 drug development 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. 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 with domicile/residence and work experience/study matching the requirements. Applications lacking these requirements will not be fully considered. Please authorize the processing of personal data (D.L. 196/2003 and GDPR 679/16). The recruitment is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-arezzo, IT

Posted Date: 5/24/2025