Tasks

Clinical Trial Applications (CTAs)
  • Interact with internal/external parties for regulatory input
  • Prepare, submit, maintain CTAs to HAs
  • Request/collect documents, arrange submission
  • Interact with HAs and ensure smooth trial running
  • Meet timelines for HA questions, End of Trial, etc.
  • Maintain tracking sheets, upload to eTMF/paper TMF


Clinical Trial Team (CTT)
  • Attend/contribute to CTT meetings
  • Discuss/prioritize country timelines
  • Advise on HA submission processes
  • Keep CTT informed on HA and regulatory matters


Other
  • Manage import/export license submissions
  • Update/create SOPs, share country info

Qualifications

2+ years' experience in clinical drug regulatory affairs or similar
  • Experience preparing CTAs and being in contact with HAs
  • Good user knowledge of TMF
  • Organized, detail-oriented team player
  • Ability to prioritize, meet deadlines, customer-focused
  • Excellent MS Office and high proficiency in English
  • Any additional European language is a plus