Our client is a market leading software company focused on the life sciences industry. Their products are innovative, over the edge and award-winning, based on standard state-of-the art technologies.
We seek to identify a Regulatory Operations Submission Manager who will manage the preparation, assembly and publishing of regulatory applications for the Professional Services Group on behalf of the company's clients.
One will work closely with the Director of Professional Services to measure, track, and ensure that all projects are proceeding to stated operational commitments.
The manager will represent the company with clients and at industry events and work closely with the Director to secure new business opportunities.
This is an opportunity for you, as the Regulatory Operations Submission Manager, to develop your own processes' and stabilize any process's with existing customers. There are processes in place currently; however they need to be re-aligned.
One must have an understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices.
An understanding of the eCTD structure as well as FDA and ICH specifications for eCTD submissions and previous hands on experience with the eCTD processes behind the compilation of INDs/NDAs/Amend/Supplements is also a must.
For consideration, one must have a Bachelor's Degree or equivalent, with a minimum of 1-3 years relevant experience. IT competency is a plus especially in MS Office.
For additional information, please contact Liz Owen at 267-483-5233 x 102 or liz@bandishgroup.