As an eCTD Regulatory Expert, a large portion of your time you will be working with customers, answering their questions and helping them analyze regulatory and functional challenges they may be experiencing. As many customers are working with tight submission timelines, a strong customer focus is critical to success. You must stay in communication with the customer and manage the situation through to resolution. A strong focus will be on Regulatory document management and eCTD submission publishing activities, helping customers to achieve technical eCTD compliance. You will also support pre-sales engagements as well as post-sales support activities.
You must have strong verbal and written communication skills and strong interpersonal skills. You are required to communicate with internal technical staff, as well as communicate externally with the customer. You need to have a good knowledge of applicable regulations and regulatory guidances. Problem-solving skills are essential. Furthermore, you will be required to work within a global team, sharing information and supporting other team members in this role. You must have good analytical skills in order to troubleshoot the situation and identify different solutions.
2+ years of direct experience as regulatory consultant / support consultant with regulatory computer systems for eCTD and/or xEVMPD and/or RIM and/or DMS systems
Demonstrate software in support of requirements gathering as well as occasional sales support.
Participate and assist with testing, configuration/release management, deployment as well as validation.
Train users via web meetings as required.
Understand customer requirements and document these as business requirements for new software functionality.
Create and maintain online support documentation.
Document issues, status, and resolutions within established systems.
Actively communicate technical and regulatory solutions to customer.
Collaborate with the technical team to determine technical solutions.
Analyze and respond to customer support tickets with solutions within established timeframes.
Work with customers to answer questions and/or resolve process or technology-related challenges within their Cunesoft environment.
Understand regulatory requirements for eCTD publishing
Understand and previous experience with GxP and/or 21 CFR Part 11
Must be flexible, independent, and self-motivated
Ability to lead customer-facing web meetings with end users, but also senior level participants
Punctual, regular, and consistent attendance
Excellent verbal and written communication skills
A good and solid understanding of regulatory processes and procedures
A good understanding of regulatory software applications
At Cunesoft, we provide intelligent software for regulatory data management to the Life Sciences Industry, delivered as Software as a Service (SaaS). Our customers benefit from process automation combined with compliant document, data and submission management. Our innovative technologies include leading edge machine learning algorithms with ready-to-use document data mining and data extraction solutions that can result in ROI’s of 12 months or less. And everything we do is supported by our global team 100% focused on client satisfaction and user happiness.