Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Pistoia col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337160 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 seeking a Global Regulatory Affairs Specialist to join their team in a 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 for 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 strategy in collaboration with GRT. Develop health authority engagement and interaction plans, including authoring and leading meetings. Maintain accurate communication with relevant HAs and track interactions. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop global dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. Contribute to and review 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 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 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 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 domicile/residence and work/study experience matching the requirements. Applications lacking these requirements will not be fully considered. Please provide authorization for data processing according to GDPR (Regulation 679/16). The research is urgent and open to candidates of both sexes (L.903/77). J-18808-Ljbffr

Location: provincia-di-pistoia, IT

Posted Date: 6/16/2025