Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Belluno col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337151 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 expanding its team. IQVIA is assisting in recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose: The role involves leveraging regulatory expertise to contribute to the development and execution of EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. The specialist supports the development and implementation of global regulatory strategies for the Target Product Profile (TPP) and ensures alignment of TPP with product labelling for development and lifecycle management. Main Responsibilities: Serve as regional/local regulatory lead and contact point internally and with health authorities. Contribute to the development of global health authority interaction strategies. Develop and manage health authority engagement and interaction plans for assigned products, including authoring and leading meetings. Maintain accurate communication and tracking with relevant health authorities. Lead regulatory sub-teams to ensure timely NDA/MAA submissions, develop global dossiers, and collaborate with GRT members. Ensure regulatory submission timelines align with project and company goals. Contribute to the content and review of regulated documents. Support operational and compliance activities, including health authority contact reports (EU & extra-EU). Support GMP, GCP, and GPV inspections. Provide updates on project and submission statuses at GRT meetings. Assist the GRL with 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. Experience with electronic document management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural environments. Soft Skills: Stress management Time management Planning and organizational skills Strategic thinking We offer: Competitive salary Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates with relevant domicile, residence, work experience, or study background. Applications lacking these requirements may not be fully considered. Applicants must consent to personal data processing as per GDPR (Regulation (EU) 2016/679). This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: belluno, IT

Posted Date: 6/16/2025