Global Regulatory Affairs Specialist

The provided job description has a generally good structure, but it contains some formatting inconsistencies and irrelevant content that can be improved for clarity and professionalism. I will remove unnecessary details such as references to social networks and streamline the content, maintaining all essential information about the role, responsibilities, and requirements. Here is the refined version: Global Regulatory Affairs Specialist, Lucca Client: Chiesi Farmaceutici Location: Lucca, Italy Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337146 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 seeking to expand their team. IQVIA has been entrusted with recruiting a Global Regulatory Affairs Specialist to join an dynamic and international working environment. Purpose: The role involves leveraging regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to achieve business objectives. The specialist supports development and execution of global regulatory strategies and ensures alignment of TPP with product labelling for development and lifecycle management. Main Responsibilities: Serve as regional/local regulatory lead and point of contact with Health Authorities. Contribute to the development of global Health Authority interaction strategies. Develop and manage Health Authority engagement plans, 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 and collaboration with GRT members. Ensure regulatory submission timelines align with project and company objectives. Review and contribute to regulated documents. Support operational and compliance activities, including inspections. Provide updates on project and submission status at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience Required: Around 3 years of experience in Regulatory Affairs. Technical Skills: Understanding of clinical development and biologics products. Knowledge of lifecycle management activities (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, work experience, and studies aligning with the requirements. Applications lacking these requirements will not be fully considered. Candidates must consent to personal data processing according to GDPR regulations. This research is urgent and open to candidates of all genders. J-18808-Ljbffr

Location: provincia-di-lucca, IT

Posted Date: 6/17/2025