POur client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with over 80 years of experience in the pharmaceutical and biotechnology industry, is expanding its team through IQVIA. They are recruiting a bGlobal Regulatory Affairs Specialist /b to join an exciting, dynamic, and international working environment. /ppbPurpose: /b /ppAs a core member of the GRT and a strategic partner of the GRL, leverage your regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly across regions to ensure the achievement of business objectives. /ppSupport the development and/or execution of the Global Regulatory Strategy to support the TPP, and ensure alignment of TPP with core product labelling for development and lifecycle management in assigned regions. /ppbMain Responsibilities: /b /pulliServe as a regional/local regulatory lead and point of contact internally and with Health Authorities. /liliContribute to the development of global HA interaction strategies in collaboration with GRT. /liliDevelop and execute Health Authority engagement and interaction plans, including authoring and moderating meetings. /liliMaintain accurate communication and tracking with relevant HAs for projects/products. /liliLead or support regulatory submissions (NDA, MAA, Variations) ensuring timelines are met, and collaborate with GRT members. /liliEnsure submission timelines align with program and company objectives. /liliContribute to and review regulated documents. /liliSupport operational and compliance activities, including HA contact reports (EU extra-EU). /liliAssist with GMP, GCP, and GPV inspections. /liliProvide updates on project and submission statuses at GRT meetings. /liliSupport updates to affiliates and interactions with IMDD and partners. /li /ulpbExperience Required: /b /ppApproximately 3 years of experience in Regulatory Affairs. /ppbTechnical Skills: /b /pulliUnderstanding of clinical development of drugs and/or biologics. /liliKnowledge of Lifecycle Management activities (EU and major extra-EU countries). /liliExperience with electronic document management systems like Veeva Vault. /liliAbility to manage multiple projects simultaneously. /liliSensitivity to multicultural/multinational environments. /li /ulpbSoft Skills: /b /pulliStress management /liliTime management /liliPlanning and organizational skills /liliStrategic thinking /li /ulpbWe Offer: /b /pulliCompetitive salary package /liliPermanent contract /liliChemical contract /li /ulpIQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and studies aligning with the role requirements. Applications lacking these requirements will not be fully considered. Candidates must authorize the processing of personal data per GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77). /ppbLICES #LIDNP /b /ppIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, supporting the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at IQVIA's website. /ppuEmployment Type: /u Full-Time /ppuExperience: /u 3 years /ppuVacancy: /u 1 /ppLocation: Milan, Lombardy, Italy /p #J-18808-Ljbffr