Requirements: English
Company: IQVIA Italia
Region: Varese , Lombardy
Our client, Chiesi Farmaceutici one of the top 50pharmaceutical companies in the world, with more than 80 years ofexperience within the pharmaceutical and biotechnology industry -in order to expand their staff, entrusted to IQVIA the recruitmentof a Global Regulatory Affairs Specialist who can join an excitingworking environment in a dynamic and international atmosphere.Purpose: As core member of the GRT and strategic partner of theGRL, leverages their regulatory expertise to contribute to thedefinition and drive the execution of aligned EU, extra-EU and/orglobal regulatory strategy working flexibly within and acrossregions to ensure the delivery of business objectives. Supportsdevelopment and/or execution of Global Regulatory Strategy tosupport the TPP Ensures alignment of TPP to core product labellingfor development/lifecycle management for the assigned region(s).Main Responsibilities: - May serve as a regional/local regulatorylead and point of contact both internally and with HealthAuthorities. - May contribute (independently or with GRL guidance)to the development of global HA interaction strategy incollaboration with GRT. - Accountable for developing, independentlyor with GRL guidance, the Health Authority engagement andinteraction plans for their assigned products incl. authoring,leading and moderating preparation meetings. - Accountable forcomplete and accurate communication/interaction (includingtracking) with the relevant HAs for the projects/products in theirremit. - Leads, independently or with GRL guidance, regulatory subteam to ensure NDA/MAA/Extensions/Variations filings meet theproject timelines, develop core global dossier, and collaborateswith other GRT members as appropriate. - Ensures that regulatorysubmission timelines are aligned with program level and companyobjectives. - Contributes to content and reviews for regulateddocuments - Supports operational and compliance activities forassigned 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 atGRT meetings. - Accountable to support the GRL on updates to theAffiliates and interactions with IMDD and partners. ExperienceRequired: Around 3 years'' experience in Regulatory AffairsEducation: Master''s degree Languages: English fluent TechnicalSkills: - Emerging understanding of clinical development of drugsand/or novel biologics products - Understanding of LCM activities(strategy and executions EU/major extra-EU countries) - Ability towork in electronic document management systems, such as Veeva Vault- Demonstrated ability to handle multiple projects/deliverablessimultaneously is preferred. - Strong sensitivity for amulticultural/multinational environment - Data readiness &competitive intelligence Soft Skills: - Team working - Stressmanagement - Time management - Planning and organizational skills -Strategic thinking We offer: - Competitive salary package -Permanent contract - Chemical contract IQVIA reserves the right toevaluate candidates with domicile / residence and work experience /study with requirements responding to the open request.Applications WITHOUT the requirements Will NOT be fully taken intoaccount. Please enter the authorization for the processing ofpersonal data (DL196/2003) - General Data Protection Regulation (13GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAsClients. The research is urgent and is intended for candidates ofboth sexes (L.903/77).