CTA / IND Regulatory Specialist

Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with Organization policy and procedures

Accountable to the functional CTA Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project

Accountability for agreed tasks and projects

Ensure independent communication, with a range of internal Organization staff, in support achievement of the assigned goals

Ensure compliance with Organization CTA process through timely action and completion of records in internal Organization systems

Ensure quality of own work to agreed timeframes, including compliance with Organization systems and record keeping

A good understanding of Clinical Trial Regulation (and Directive), DIA TMF Reference Model and CTA submission requirements for multiple countries / submission types