Regulatory Affairs Specialist II

Prepare and maintain electronic submissions (eCTD) of DMFs, via a publishing system, according to industry guidelines.
Submission of DMFs, prepared by RA team, to authorities according to relevant guidelines.
Routine support and collaboration with the Regulatory Affairs Associates team members in administrative activities related to submissions and technical preparation of DMFs.
Answering and supporting customers' requests by providing administrative information (DMFs, CEPs, Deficiency letters responses prepared by RA team) and additional categories as needed, via CRM.
Filling RA documents in CRM and Smarteam systems.
Distribution of costumer notifications prepared by RA team via the CRM system.
Learning of submission regulatory guidance and internal work processes
Working with several submission systems in parallel and different gateways according to authority's requirements.