Primary purpose and function of this position:
o Lead, manage and coordinate clinical trials application (CTAs in EU countries and IND in US) by close cooperation with assigned CROs and the relevant functions inhouse , this includes:
§ Putting together the submission package in collaboration with relevant functions (CMC, pre-clinical, clinical,device).
§ Follow up with CRO/Clinical Operation to secure on time quality submission
§ Secure timely and quality Response to authorities’ deficiency letters
§ Manage database to archive history of communication
§ Annual updates (DSURs)
§ Amendments, any other notification
§ End of trial activities (notifications and end of trial report submission)
o Attend clinical forum meetings/discussions as needed
o Establish or improve processes and working practises to define above tasks and other required regulatory policies / procedures
o Contribute to the compilation and critically review of clinical regulatory documentations
o Regulatory Intelligence – Track, interpret and advise on US and European regulations, guidelines, procedures and policies within the scope of the company, with focus on clinical discipline
Other Major duties and Responsibilities:
· Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory aspects are considered throughout the development and submission process.
· Review strategic correspondence with authorities, pivotal for CTA/IND submissions (briefing books, Scientific advice, deficiency letters etc.)
· Maintain regulatory documentation (such as IMPD, IB, IND) and archiving system.
· Supervise Regulatory Affairs consultants as required.
· Top responsibility for M1/local data in submission to all countries/territories
· Operational support for NDA/MAA (e-CTD, publishing)
· Other duties as assigned.