Responsibilities
- Responsible for overall planning and execution of regulatory and ethics submissions for assigned projects/countries (all regions especially Europe)/sites, which may include completion of submissions or notifications, as required
- Direct and oversee short-term and long-term planning of regulatory submission initiatives
- Develop and implement strategies for the earliest possible approval of regulatory submission
- Responsible for review and compilation of the Clinical trial application dossier (including associated documentation)
- Responsible for submission of the Clinical trial application dossier through the CTIS portal for Europe or another applicable regulatory portal
- Responsible for providing advice and support to the project team for regulatory aspects of the clinical trials and late phase studies
- Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Clinical Regulatory Affairs activities (update of Tracking tables, internal and external database)
- Responsible for liaising with other departments on requirements for regulatory and ethics submissions
- Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form
- Prepare responses to inquiries / comments from regulatory authorities on the CTA dossier or related documents
- Maintaining an up-to-date knowledge of the European and other applicable regulatory requirements and processes