Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, vercelli col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337169 Job Views: 1 Posted: 08.05.2025 Expiry Date: 22.06.2025 col-wide 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 expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment. Purpose: The specialist is a core member of the GRT and a strategic partner of the GRL, leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies across regions to meet business goals. They support the development and execution of global regulatory strategies to support the TPP and ensure alignment of TPP with core product labeling for development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with Health Authorities. Contribute to developing global HA interaction strategies with GRT guidance. Develop and manage health authority engagement and interaction plans for assigned products, including authoring and leading meetings. Ensure accurate communication and tracking with relevant HAs. Lead regulatory sub-teams to meet filing timelines, develop core dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. 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 project and submission updates at 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 organizational skills Strategic thinking We offer: Competitive salary Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, or studies matching the requirements. Applications without the required qualifications will not be fully considered. Consent for data processing is required per GDPR regulations. The position is open to all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-vercelli, IT

Posted Date: 6/17/2025