Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Latina col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337153 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 their team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment. Purpose: As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to contribute to the development and execution of 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 to support the TPP. Ensure alignment of TPP with core product labelling for development/lifecycle management in assigned regions. Main Responsibilities: Serve as 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, including authoring and leading meetings. Communicate and track interactions with relevant HAs for assigned projects/products. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core 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). Assist with GMP, GCP, and GPV inspections. Provide project and submission updates 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: Details not specified. Languages: Details not specified. Technical Skills: Understanding of clinical development of drugs and biologics. Knowledge of Life Cycle 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 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 studies. Applications without the required qualifications will not be fully considered. Please authorize the processing of personal data according to GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-latina, IT

Posted Date: 5/24/2025