Operations RA Associate

Primary purpose and function of this position:
o   o  Manage and coordinate clinical trials application (CTAs in EU countries and IND in US) by close cooperation with assigned CROs and the relevant functions at Neuroderm, this includes:
§ Compilation of 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
§ Amendments, any other notification
§ End of trial activities (notifications and end of trial report submission)
o  Attend clinical forum meetings/discussions with CRO as needed
o  Support GCO needs from a regulatory perspective
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:
·        Maintain regulatory documentation (such as IMPD, IB, IND) and archiving system.
·        Supervise Regulatory Affairs consultants as required.
·        Operational support for NDA/MAA (Veeva, e-CTD, publishing)
·        Operational support of regulatory meetings
·        Other duties as assigned.