pOn 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 strongemGlobal Rare Disease /em Regulatory Affairs Specialist emEUINT /em /strong to join an exciting working environment in a dynamic and international atmosphere. /ppbr / /ppstrongMain regulatory responsibilities /strong: /pulliUnder guidance of the manager, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline; /liliIn collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products; /liliCritically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission; /liliUpon request of the manager, provides regulatory guidance to colleagues from other functional areas; /liliPrepares responses to questions and/or information requests from regulatory agencies within the timeframes specified; /liliLiaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions; /liliUses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products. /li /ulpbr / /ppstrongRequirements /strong:



/pulli2-3 years experience in regulatory affairs in EU or INT or both at corporate level in a multinational company; /liliExperience and knowledge in the life cycle management of regulatory filing; /liliAbility to work under supervision in the preparation of high-quality submissions and submission documents; /liliStrong attention to details and quality of documents and processes; /liliWell-developed written and oral communication and listening skills; /liliWell-developed time management skills and demonstrated ability to manage complex assignments; /liliWell-developed analytical and problem-solving skills; /liliAbility to work independently and as part of a team; /liliEnglish level from advanced to fluency; /liliGood IT skills level. /li /ulpbr / /ppstrongType of contract: /strong /pullistrongNational Collective Labour Agreement: /strong Chemical and Pharmaceutical Industry; /lilistrongContract Type: /strong Staff Leasing with IQVIA; /lilistrongSalary Range or Gross Annual Salary: /strong from 40.500€ to 50.600€ RAL. /li /ulpbr / /ppThe role also includes: /pulliprivate health insurance (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector); /lilipension fund (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector); /liliflexible benefits/corporate welfare. /li /ulpbr / /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

📌 GRD Regulatory Affairs Specialist EU&INT (Parma)
🏢 IQVIA Italia
📍 Parma