10 set - Roma
IQVIA Italia
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. 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 fordeveloping, 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 regulated documents; Supports operational and compliance activities for assigned deliverables, HA contact report (EU & EXTRA-EU); Supports GM
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