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
Experience
Education: Life science degree, pharmacist education is a plus
Strong knowledge of ICH/GCP guidelines or other relevant guidelines
Good understanding of Clinical trial regulation and the Clinical trial information system
Ideally EU / Global experience (2 to 3 Years)
Proficiency with computer systems
Strong verbal and written communication skills in English, any other language is a plus
Strong organizational, time management, interpersonal skills.
team player spirit
Ability to work both independently and in a team environment
