Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Bergamo Client: Location: Job Category: Other - EU work permit required: Yes Job Reference: 8160257735766573056337110 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 biotechnology industry, has entrusted IQVIA with recruiting a Global Regulatory Affairs Specialist to join their dynamic and international team. Purpose: The successful candidate will be a core member of the GRT and a strategic partner of the GRL, leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Responsibilities include supporting the development and execution of global regulatory strategies, ensuring alignment of TPP with product labeling for development and lifecycle management, and serving as a regulatory lead or contact with health authorities. Main Responsibilities: Serve as a regional/local regulatory lead and contact point 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 for assigned products, including authoring and leading meetings. Ensure accurate communication and tracking with relevant health authorities. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings and collaborate with GRT members. Align regulatory submission timelines with project and company objectives. Contribute to content review for regulated documents. Support operational and compliance activities, including health authority contact reports (EU & EXTRA-EU). Assist with GMP, GCP, and GPV inspections from health authorities. 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 drug 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. Applications without meeting the specified requirements will not be fully considered. Candidates must authorize the processing of personal data according to GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-bergamo, IT

Posted Date: 6/17/2025