Requirements: English
Company: JR Italy
Region: Lecco , Lombardy
Social network you want to login/join with:Global Regulatory Affairs Specialist, LeccoClient:Location:Job Category: Other-EU work permit required: YesJob Reference:8160257735766573056337154Job Views:1Posted:08.05.2025Expiry Date:22.06.2025Job 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 staff. 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 define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives.Support development and execution of Global Regulatory Strategy to support the TPP, ensuring alignment of TPP with core product labelling for development and lifecycle management in assigned regions.Main Responsibilities:Serve as regional/local regulatory lead and contact point internally and with Health Authorities.Contribute to global HA interaction strategy development with guidance from GRL.Develop, independently or with GRL guidance, Health Authority engagement and interaction plans, including authoring and leading meetings.Ensure accurate communication with relevant HAs, including tracking interactions.Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core global dossiers, and collaborate within GRT.Align regulatory submission timelines with program and company objectives.Contribute to content and review of 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 updates on project and submission status at GRT meetings.Assist GRL with 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 drug development and/or biologics.Knowledge of Lifecycle Management activities in EU and major extra-EU countries.Proficiency with electronic document management systems like Veeva Vault.Ability to handle multiple projects simultaneously.Sensitivity to multicultural/multinational environments.Soft Skills:Stress managementTime managementPlanning and organizational skillsStrategic thinkingWe Offer:Competitive salary packagePermanent contractChemical contractIQVIA reserves the right to evaluate candidates based on domicile/residence and work/study experience matching the requirements. Applications without the required qualifications will not be fully considered. Please provide consent for personal data processing (D.L. 196/2003 and GDPR 679/16) for IQVIA and its clients. The recruitment is urgent and open to all genders (L.903/77).#J-18808-Ljbffr