Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Bari col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337117 Job Views: 1 Posted: 08.05.2025 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: As a core member of the GRT and strategic partner of the GRL, leverage your regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and global regulatory strategies. Work flexibly across regions to ensure business objectives are met. Support the development and execution of Global Regulatory Strategy to support the TPP. Ensure alignment of TPP with core product labelling for development and lifecycle management in assigned regions. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with Health Authorities. Contribute to the development of global HA interaction strategies in collaboration with GRT. Develop, independently or with GRL guidance, health authority engagement and interaction plans for assigned products, including authoring and leading meetings. Communicate and track interactions with relevant HAs for projects/products. Lead regulatory sub-teams to ensure NDA/MAA/Extensions/Variations filings meet timelines, develop core dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. Review and contribute to regulated documents. Support operational and compliance activities for deliverables and HA contact reports (EU & extra-EU). Support GMP, GCP, and GPV inspections from health authorities. 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: Relevant educational background. Languages: Proficiency in relevant languages. Technical Skills: Understanding of clinical development of drugs and biologics. 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 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 relevant domicile, residence, work experience, or study background. Applications lacking the required qualifications will not be fully considered. Please authorize the processing of personal data in accordance with GDPR (Regulation 679/16). This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-bari, IT

Posted Date: 6/17/2025