Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, macerata col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337163 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 in the world, 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 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 the development and execution of Global Regulatory Strategy for the TPP. Ensure alignment of TPP with core product labelling for development and lifecycle management in assigned regions. Main Responsibilities: Serve as regional/local regulatory lead and point of contact internally and 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 and tracking with relevant HAs. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members. Align regulatory submission timelines with project and company goals. Contribute to and review regulated documents. Support operational and compliance activities, including HA contact reports (EU & EXTRA-EU). Assist with GMP, GCP, and GVP inspections. Provide updates on project and submission statuses at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years in Regulatory Affairs. Education: Details not specified. Languages: Details not specified. Technical Skills: Understanding of clinical drug development and biologics. Knowledge of LCM activities in EU and major extra-EU countries. Experience with electronic document management systems like Veeva Vault. Ability to manage multiple projects simultaneously. Multicultural/multinational environment sensitivity. Soft Skills: Stress management Time management Planning and organizational skills Strategic thinking We Offer: Competitive salary package Permanent contract Chemical contract IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and studies. Applications without meeting the requirements will not be fully considered. Consent for data processing is required according to GDPR. This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-macerata, IT

Posted Date: 6/1/2025