EXTEDO is of the leading names in the field of Regulatory Information Management (RIM). With our EXTEDOpulse solutions and expert consultants, we are on a mission to enable agencies and life sciences organizations around the world to bring new products to market faster and safer. EXTEDO enables more than 35 regulatory authorities and over 850 maintained customers across 60 countries to deliver Effortless Compliance. Our clients range from small CROs to large multi-national pharmaceutical organizations. The areas of Life Sciences in which EXTEDO operates are: pharmaceuticals, biotech and biopharma, generics, medical devices, healthcare and the public sector. We are still growing!

For our location in Ottobrunn near Munich or in remote we are actively seeking a

 

Working student Publishing, Regulatory Operations (m/f/d)

Your Tasks - as important as our Software:

 
  • Support in publishing valid eCTD submissions using EXTEDOs publishing tools (e.g. eCTDmanager) for a variety of regions e.g. EU, FDA, HC, EAEU etc.
  • Perform document publishing whilst ensuring that documents are ICH PDF eCTD compliant using various document publishing tools
  • Perform quality checks on submissions and documents
  • Troubleshoot and resolve or report any compliance issues to the product management
  • Cooperate with EXTEDOs Regulatory Intelligence Centre department on regulatory knowledge topics and broaden your regulatory knowledge continuously
  • Strong collaboration and exchange with the publishing team, whilst being initiative and proactive in e.g. solving issues

Your Profile - as good as our Solutions:

 
  • Enrolled student in Pharmacy, Biomedical Engineering or a comparable study
  • Able to work 20 hours per week
  • First work experience as e.g. an intern or working student
  • Good knowledge of Windows (including SharePoint, Outlook, Word, Excel) and Adobe Acrobat
  • Excellent English communication skills, verbally and in writing
  • Extensive organizational and time management skills as well as strong attention to detail to ensure clients' deadlines are met and high quality of service delivery is maintained
  • First regulatory know-how on eCTD and regulatory publishing processes is a plus but not mandatory
Being an EXTEDOrian means being part of something big. It means working with the future of regulatory topics in the pharmaceutical area, the future of our company and at the very same time: your future. At EXTEDO, we believe in hiring people like you: detail-oriented, forward thinkers who want to be more than just another employee.