Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Reggio Emilia Client: Location: Job Category: Other - EU work permit required: Yes Job Reference: 8160257735766573056337116 Job Views: 1 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 is assisting in recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment. Purpose: The specialist acts as a core member of the GRT and strategic partner of the GRL, leveraging regulatory expertise to help define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Supports the development and execution of global regulatory strategies to support the TPP and ensures alignment of TPP with core product labelling during development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with health authorities. Contribute to developing global HA interaction strategies with GRT guidance. Develop and manage health authority engagement and interaction plans for assigned products, including authoring and leading meetings. Maintain accurate communication and tracking with relevant HAs. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members. Ensure submission timelines align with project and company goals. 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 with domicile/residence and work experience/study matching the requirements. Applications without the specified requirements will not be fully considered. Please provide consent for data processing according to GDPR (L.903/77, GDPR 679/16). The recruitment is urgent and open to all genders. J-18808-Ljbffr

Location: reggio-emilia, IT

Posted Date: 6/16/2025