Global Regulatory Affairs Specialist

Global Regulatory Affairs Specialist, Ravenna Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337125 Job Views: 2 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 biotechnology industry – is expanding its team. IQVIA has been entrusted with recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose: The specialist will be a core member of the GRT and a strategic partner to the GRL, leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies. They will work flexibly within and across regions to ensure the achievement of business objectives, support the development and execution of global regulatory strategies for the TPP, and 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 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 dossiers, and collaborate with GRT members. Ensure regulatory submission timelines align with program and company objectives. Contribute to content review for regulated documents. Support operational and compliance activities, including HA contact reports (EU & extra-EU). Assist with GMP, GCP, and GPV inspections from health authorities. Provide updates on project and submission status at GRT meetings. Support the GRL in updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years of experience in Regulatory Affairs. Education: Languages: Technical Skills: Emerging understanding of clinical development of drugs and/or biologics. Understanding of lifecycle management activities in EU and major extra-EU countries. Ability to work with electronic document management systems, such as 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 based on residence, work experience, or studies matching the open requirements. Applications without the required qualifications will not be fully considered. Please provide consent for data processing in accordance with GDPR (Regulation 679/16). Note: If you are not a passport holder of the country where the vacancy is located, a work permit may be required. For more information, consult our blog. Applicants should apply via the 'Apply now' button. Do not include bank or payment details in your application. IQVIA is not responsible for external website content. J-18808-Ljbffr

Location: provincia-di-ravenna, IT

Posted Date: 5/12/2025