Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Padova Client: Location: Job Category: Other - EU work permit required: Yes Job Reference: 816025773576657305633716 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 – has entrusted IQVIA to recruit a Global Regulatory Affairs Specialist . The candidate will join a dynamic, international environment. Purpose: The specialist will be a core member of the GRT and a strategic partner of the GRL, leveraging regulatory expertise to help define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Responsibilities include supporting the development and execution of global regulatory strategies for the TPP, and ensuring alignment of TPP with core product labeling for development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and contact point internally and with Health Authorities. Contribute to global health authority interaction strategies in collaboration with GRT. Develop health authority engagement plans, authoring and leading meetings. Manage communication and interactions with health authorities for assigned projects. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings and collaborate with GRT members. Ensure regulatory submission timelines align with program and company goals. Review and contribute to regulated documents. Support operational and compliance activities, including HA contact reports (EU & EXTRA-EU). Assist with GMP, GCP, and GPV inspections. Provide updates on project and submission statuses in GRT meetings. 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 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 organization Strategic thinking We offer: Competitive salary Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates with relevant domicile/residence and work/study experience. Applications not meeting the requirements will not be fully considered. Please provide authorization for personal data processing under GDPR (L.903/77, 13 GDPR 679/16). This research is urgent and open to candidates of all genders. J-18808-Ljbffr

Location: padova, IT

Posted Date: 6/1/2025