• Leading regulatory IT projects including software upgrades, and identification and implementation of new solutions
• Technical maintenance and support of regulatory IT systems (e.g. regulatory database, publishing software, validation tools) including user training and assistance
• Acting as primary interface between the Regulatory Affairs department and IT
  Monitoring and implementing authority-specific regulatory IT systems (e.g. submission portals, HC-REP, SPL, EMA IT systems)
• Staying informed and implementing of technical regulatory requirements (e.g. eCTD 4.0, ePI, eAF, pilot projects with authorities, onboarding of new countries to eCTD)
• Ensuring compliance with internal SOPs and applicable regulations through the regular review and application of relevant directives
• Performing data compliance checks to ensure adherence to SOPs and local regulations
• Preparation of registration dossiers and maintaining accurate product records in the registration database

Your profile that will convince us:

• Completed University degree in natural sciences (or related)
• 3-5 years working experience in Regulatory Affairs, Regulatory Affairs IT or Regulatory Compliance
• Project management skills are beneficial
• Very good communication skills in Business English, German is a plus
• Strong problem-solving and analytical skills as well as organizational strength
• Technically proficient, with experience using databases, document processing tools, spread-sheets, and emerging digital solutions such as AI
• Able to work in a team environment with shifting priorities and requirements