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 we are actively seeking a
Junior Publishing Consulting, Regulatory Operations (m/f/d)
Your Tasks - as important as our Software:
- Publish 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
- Work closely with EXTEDOs Regulatory Intelligence Centre department on some regulatory knowledge topics and attend regulatory knowledge training
- 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:
- Degree in Biology, Biomedical Engineering or a comparable study. Masters degree preferred.
- First work experience in software or life science-related industry
Proficient 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. Ability to effectively manage multiple tasks/projects and prioritize time with strong attention to detail to ensure clients' deadlines are met and high quality of service delivery is maintained
- Sound regulatory know-how on eCTD and regulatory publishing processes is preferable