Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Salerno Job Details: Client: Chiesi Farmaceutici Location: Salerno Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337149 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, is looking to expand their team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an dynamic and international environment. Purpose: As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to achieve business objectives. Support development and execution of global regulatory strategies for the TPP and ensure alignment of TPP with product labeling for development and lifecycle management. Main Responsibilities: Serve as regional/local regulatory lead and point of contact with health authorities. Contribute to global HA interaction strategies. Develop health authority engagement plans and lead meetings. Communicate and track interactions with health authorities. Lead regulatory sub-teams for filings like NDA, MAA, and variations, ensuring timelines are met. Align regulatory submission timelines with project and company objectives. Review and contribute to regulated documents. Support operational and compliance activities, including inspections. Provide project updates at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience and Skills: Approximately 3 years' experience in Regulatory Affairs. Knowledge of clinical development and biologics products. Understanding of lifecycle management activities in EU and major extra-EU countries. Proficiency with electronic document management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural environments. Soft Skills: Stress and time management. Planning and organizational skills. Strategic thinking. What We Offer: Competitive salary package. Permanent contract. Chemical contract. IQVIA reserves the right to evaluate candidates with domicile/residence and work experience/study matching the requirements. Applications lacking these requirements will not be fully considered. Please authorize the processing of personal data as per GDPR regulations. This urgent research is open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: salerno, IT

Posted Date: 6/16/2025