Sr. Regulatory Affairs, Study Start Up Specialist / Regulatory Affairs, Study Start Up Specialist II (Level Dependent on Experience)

ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE REVIEWED!

Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment, and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.