Operational clinical trials RA Manager

Primary purpose and function of this position:
  
 *Lead, manage and coordinate clinical trials application (CTAs in EU countries OR IND in US) by close cooperation with assigned CROs and the relevant functions, 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 submission
 *Coordinate Response to authorities’ deficiency letters while ensuring on-time quality response
 *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)
 *Building in collaboration with the CROs and Company’s operational center a Q&A Log for relevant Authorities questions
 *Establish or improve processes and working practises to define above tasks and other required regulatory policies / procedures and perform corresponding trainings as required
 *Contribute to the compilation and critically review of any regulatory documentations
 *Track, interpret and advise on US and European regulations, guidelines, procedures and policies within the scope of the company
  
 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.
 *Track, interpret and advise on US and European regulations, guidelines, procedures and policies within the scope of the company.
 *Top responsibility for M1/local data in submission to all countries/territories
 
 *Other duties as assigned.
 
 Reports To: VP RA