10 set - Emilia-Romagna
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 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 regulated documents;
- Supports operational and compliance activities for assigned deliverables, HA contact report (EU & EX
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