Global Regulatory Affairs Specialist

Social network you want to login/join with: Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337157 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 in the world, with over 80 years of experience in the pharmaceutical and biotechnology industry, is expanding its staff. IQVIA is recruiting a Global Regulatory Affairs Specialist to join a dynamic and international environment. Purpose: The role involves leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Supports development and implementation of global regulatory strategies for the TPP and ensures alignment of TPP with core product labelling for development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and contact point with health authorities. Contribute to global health authority interaction strategies. Develop and manage health authority engagement and interaction plans. Ensure accurate communication with health authorities and track interactions. Lead regulatory sub-teams for NDA/MAA/Extensions/Variations filings, ensuring timely submissions. Align regulatory submission timelines with project and company objectives. Review and contribute to regulated documents. Support operational and compliance activities, including health authority reports. Assist with GMP, GCP, and GPV inspections. Provide updates on project and submission status. 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 and biologics. Knowledge of lifecycle management activities. Experience with electronic document management systems like Veeva Vault. Ability to handle multiple projects. 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 based on domicile/residence and work/study experience. Applications without the required qualifications will not be fully considered. Consent for data processing according to GDPR is required. The research is urgent and open to candidates of all genders. J-18808-Ljbffr

Location: provincia-di-biella, IT

Posted Date: 6/18/2025