Global Regulatory Affairs Manager-Maternity Cover

ppOn behalf of our Client, bChiesi Farmaceutici /b, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, bIQVIA /b is looking for ab Global /b bRegulatory Affairs Manager /b b(fixed-term maternity cover) /b to join an exciting working environment in a dynamic and international atmosphere. /ph3Purpose: /h3pAs 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. /ppSupports development and/or execution of Global Regulatory Strategy to support the TPP. /ppEnsures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s). /ph3Main Responsibilities: /h3ulliMay serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities; /liliMay contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT; /liliAccountable 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; /liliAccountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit; /liliLeads, 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; /liliEnsures that regulatory submission timelines are aligned with program level and company objectives; /liliContributes to content and reviews for regulated documents; /liliSupports operational and compliance activities for assigned deliverables, HA contact report (EU EXTRA-EU); /liliSupports GMP, GCP, and GPV inspections from health authorities; /liliAccountable to provide updates on project and submissions status at GRT meetings; /liliAccountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners. /li /ulh3Experience Required: /h3ulliAround 3-4 years' experience in International Regulatory Affairs; /liliExperience in regulatory affairs within rare diseases is preferred. /li /ulh3Education: /h3h3Languages: /h3h3Technical Skills: /h3ulliEmerging understanding of clinical development of drugs and/or novel biologics products; /liliUnderstanding of LCM activities (strategy and executions EU/major extra-EU countries); /liliAbility to work in electronic document management systems, such as Veeva Vault; /liliDemonstrated ability to handle multiple projects/deliverables simultaneously is preferred ; /liliStrong sensitivity for a multicultural/multinational environment ; /liliData readiness competitive intelligence ; /li /ulh3Soft Skills: /h3ulliStress management; /liliTime management; /liliPlanning and organizational skills; /liliStrategic thinking. /li /ulh3Type of contract: /h3pNational Collective Labour Agreement: Chemical and Pharmaceutical Industry; /ppContract Type: Fixed Term-temporary position covering maternity leave; /ppSalary Range or Gross Annual Salary: from 46.000€ to 57.000€ RAL. /ppThe salary range is defined based on experience, skills, and internal equity criteria. Career progression and compensation review are based on transparent, objective criteria. We are committed to fair and equal pay practices, in line with applicable pay transparency regulations (EU Directive 2023/970). /ppIQVIA 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 IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77). /p /p #J-18808-Ljbffr