Regulatory and Start up Manager

10 hours ago


Budapest, Budapest, Hungary IQVIA Full time

Responsible for coordinating the operational and strategic aspects for Clinical Trial Submissions

Essential Functions

  • Lead the submission process from strategy formation to clinical trial approval
  • Coordinate creation of trial submissions strategy development, planning and delivery
  • Responsible for Quality checks on CTIS before submissions
  • Financial planning an tracking
  • Driving discussions, consolidates inputs from stakeholders and facilitate CTR submission strategy
  • Responsible for Coordinating submissions in the CTIS portal

Qualifications

  • 3 to 5 years experience building RDC databases in support of clinical research
  • Experience in regulatory and submissions
  • Project management skills

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more



  • Budapest, Budapest, Hungary TFS HealthScience Full time

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.*Join Our Team as aFreelanceStudy Start Up Specialist (SSU...


  • Budapest, Budapest, Hungary IQVIA Full time

    Responsible for coordinating the operational and strategic aspects for Clinical Trial SubmissionsEssential Functions:- Lead the submission process from strategy formation to clinical trial approval- Coordinate creation of trial submissions strategy development, planning and delivery- Responsible for Quality checks on CTIS before submissions- Financial...


  • Budapest, Budapest, Hungary Wizz Air Full time

    Wizz Air is a leading European low-cost airline. Our mission is to provide affordable and reliable air travel to everyone, everywhere, while minimizing our environmental impact. We are proud to foster a diverse and inclusive team of over 8,000 employees from more than 110 nationalities, who share our values of inclusivity, positivity, dedication, integrity,...


  • Budapest, Budapest, Hungary SOFMEDICA Full time

    SOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe.We are looking for a Quality and Regulatory Specialist to join...


  • Budapest, Budapest, Hungary Citi Full time

    Join our expanding Citi Finance Team in Budapest and make your own progress in a supportive and friendly environmentWe are a people-oriented organization that appreciates and promotes personal and professional aspirations. Our corporate culture is empathic: we acknowledge life-work balance throughout your career path.Regulatory Reporting Group...


  • Budapest, Budapest, Hungary Citi Full time

    The Regulatory Reporting role is an analyst position within the Controllers Organization that will report up through the Global Head of Regulatory and Capital Reporting. The individual will support the preparation, analysis and submission of regulatory reports to various constituencies (local regulators, U.S. Federal Reserve, OCC, etc.) based on applicable...


  • Budapest, Budapest, Hungary Citi Full time

    Discover your future at CitiWorking at Citi is far more than just a job. A career with us means joining a team of more than 230,000 dedicated people from around the globe. At Citi, you'll have the opportunity to grow your career, give back to your community and make a real impact.Job OverviewThe Regulatory Reporting role is an analyst position within the...


  • Budapest, Budapest, Hungary Abacus Medicine Group Full time

    About the roleAs Deputy Manager, you will lead one of the teams in our Regulatory Affairs department, responsible for new applications and ongoing maintenance of licenses for parallel traded medicines. Your focus will be on ensuring timely, high-quality applications to health authorities, managing a team of approximately 8–15 people, depending on your...

  • Regulatory Team Lead

    2 weeks ago


    Budapest, Budapest, Hungary Cognizant Full time €80,000 - €120,000 per year

    Regulatory Team LeaderThe position exists to participate in the regulatory program of our pharmaceutical partner, being part of a global team and leading a team which is part of it.Job LocationBudapest, Hungary 9th District – Mill Park Office BuildingWorking Hours 40 hours per week Normal business hoursOffice attendance: Once a weekOfferCompetitive salary...


  • Budapest, Budapest, Hungary IQVIA Full time

    IQVIA is looking to hire a motivated Clinical Trial Assistant, Single Sponsor Dedicated, HungaryJob Overview:CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of...