As a Regulatory Consultant, a large portion of your time you will be spent working with customers (many times via our Zendesk support platform), answering their questions, and helping them to analyze regulatory and functional challenges they may be experiencing. A strong focus will be on Regulatory document management and eCTD submission publishing activities, helping customers to achieve technical submission compliance. You will also support pre-sales engagements as well as post-sales support activities.what we offer
- 100% remote
- LUXMED private medical care and the possibility of life insurance on preferential terms
- KAFETERIA benefit platform and Multisport card
- Employee Assistance Program (psychological and mentoring support available for employees and their families)
- Opportunities to develop qualifications through the PhlexAcademy training platform
- Additional days off and attractive jubilee gratuities
- Employee Referral reward
- Integration events
- Great atmosphere & international environment
- Work with customers to answer questions and/or resolve process or technology-related challenges
- Analyze and respond to customer support tickets with solutions within established timeframes.
- Collaborate with the technical team to determine technical solutions.
- Actively communicate technical and regulatory solutions to customer.
- Document issues, status, and resolutions within established systems.
- Create and maintain online support documentation, rrain users via web meetings as required.
- Understand customer requirements and document these as business requirements for new software functionality.
- Participate and assist with testing, configuration/release management, deployment as well as validation.
- Direct experience as regulatory consultant / support consultant with regulatory computer systems for eCTD and/or xEVMPD and/or RIM and/or DMS systems
- Understand regulatory requirements for eCTD publishing
- Understand and previous experience with GxP and/or 21 CFR Part 11
- Ability to lead customer-facing web meetings with end users, but also senior level participants
- Excellent verbal and written English skill
- A good and solid understanding of regulatory processes and procedures
Employment agency entry number 47
this job offer is intended for people over 18 years of age...