On behalf of our Client, Chiesi Farmaceutici , one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Global Regulatory Affairs Manager (fixed-term maternity cover) to join an exciting working environment in a dynamic and international atmosphere.
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Purpose: As core member of the GRT and strategic partner of the GRL, leverages their regulatory expertise to contribute to the definition and drive the execution of aligned EU, extra-EU and/or global regulatory strategy working flexibly within and across regions to ensure the delivery of business objectives.
Supports development and/or execution of Global Regulatory Strategy to support the TPP.
Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).
Main Responsibilities:



May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities; May contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT; Accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products incl.
authoring, leading and moderating preparation meetings; Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit; Leads, independently or with GRL guidance, regulatory sub team to ensure NDA/MAA/Extensions/Variations filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate; Ensures that regulatory submission timelines are aligned with program level and company objectives; Contributes to content and reviews for

📌 Global Regulatory Affairs Manager-Maternity Cover (Ramiola)
🏢 IQVIA Italia
📍 Ramiola