Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Varese Client: Location: Job Category: Other - EU work permit required: Yes Job Reference: 8160257735766573056337121 Job Views: 1 Posted: 08.05.2025 Job Description: Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies worldwide, with over 80 years of experience in the pharmaceutical and biotech industry – is expanding its team. 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 contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Support the development and execution of global regulatory strategies for the TPP, ensuring alignment 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 global health authority 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 health authorities. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop global dossiers, and collaborate with GRT members. Ensure regulatory submission timelines align with program and company goals. Review and contribute to regulated documents. Support operational and compliance activities, including health authority contact reports (EU & EXTRA-EU). Assist with GMP, GCP, and GPV inspections. Provide updates on project and submission status at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years of experience in Regulatory Affairs. Education: Languages: Technical Skills: Understanding of clinical development and biologics products. 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/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, work experience, and studies aligning with the requirements. Applications lacking these requirements will not be fully considered. Please authorize the processing of personal data (DL196/2003) under GDPR. This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: Varese, Lombardia, IT

Posted Date: 7/8/2025