Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Mantova Job Details: Client: Chiesi Farmaceutici Location: Mantova Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337124 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 in the industry—seeks a Global Regulatory Affairs Specialist to join their team in a dynamic, 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 meet business objectives. Support development and execution of Global Regulatory Strategy for the TPP, ensuring 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 global HA interaction strategies in collaboration with GRT. Develop and manage Health Authority engagement plans, including authoring and leading meetings. Maintain accurate communication with relevant HAs and track interactions. Lead regulatory sub-teams to ensure timely submissions of NDAs, MAAs, extensions, and variations, developing core global dossiers. Ensure submission timelines align with project and company goals. Contribute to document content and reviews. Support operational and compliance activities, including HA contact reports (EU & extra-EU). Assist in GMP, GCP, and GPV inspections. Provide updates on project and submission status at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years in Regulatory Affairs. Skills & Qualifications: Understanding of clinical development and biologics. Knowledge of Lifecycle Management activities in EU and major extra-EU countries. Proficiency with electronic document management systems like Veeva Vault. Ability to manage multiple projects simultaneously. Sensitivity to multicultural environments. Soft Skills: Stress and time management Organizational and planning 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 lacking these requirements will not be fully considered. Please authorize the processing of personal data according to GDPR (Regulation 679/16). This urgent search is open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-mantova, IT

Posted Date: 6/17/2025