BioNTech SE
Mainz, RP, DE, 55116
Mainz, Germany; Munich, Germany | full time | Job ID: 9799
You will define and manage Regulatory Operations activities of EU Clinical Trial Application (CTA) submissions in the Clinical Trials Information System (CTIS) in compliance to the EU Clinical Trial Regulation (EU CTR). Support the strategic refinement, coordination, and continuous improvement of cross-functional processes for CTAs and clinical trial maintenance in compliance with the EU CTR.
Y our main responsibilities:
Manage submissions of EU CTAs according to project plans and as defined in SOPs and work instructions, including entering of data and upload of documents, as well as monitoring of CTIS for Requests for Information (RFIs) and other authorities’ responses in close alignment with the relevant team members. Further you will be responsible for maintenance of CTAs in CTIS and CTA monitoring and result reporting
Ensure the EU CTR compliant use of CTIS within a...
