Requirements: English
Company: IQVIA Italia
Region: Pavia , Lombardy
Our client, Chiesi Farmaceutici one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a Global Regulatory Affairs Specialist who can 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 TPPEnsures 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 & EXTRA-EU).- Supports GMP, GCP, and GPV inspections from health authorities.- Accountable to provide updates on project and submissions status at GRT meetings.- Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.Experience Required:Around 3 years'' experience in Regulatory AffairsEducation:Master''s degreeLanguages:English fluentTechnical Skills:- Emerging understanding of clinical development of drugs and/or novel biologics products- Understanding of LCM activities (strategy and executions EU/major extra-EU countries)- Ability to work in electronic document management systems, such as Veeva Vault- Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.- Strong sensitivity for a multicultural/multinational environment- Data readiness & competitive intelligenceSoft Skills:- Team working- Stress management- Time management- Planning and organizational skills- Strategic thinkingWe offer:- Competitive salary package- Permanent contract- Chemical contractIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).