R&D Regulatory submission systems

Role Description:
• L2/L3 Support: Service requests, incident resolution, release management, minor enhancement on list of regulatory submission applications.
• Performing Computer System Validation activities and authoring documents for regulatory submission systems in the Biotech/Pharmaceutical Industry


Skills Requirements:
• The person must come from IT Departments (R&D IT support) from Pharma or/and Biotech industries and should have ITIL knowledge (Incident/Change/Knowledge/Problem Management).
• Some knowledge of and experience in Regulatory Information Management System Administration, Regulatory Submission Process and Regulatory Affairs business processes workflows involved in interaction with Health Authorities i.e FDA. And EMA.
• Technical skills: Windows Server, Documentum, DQL/SQL
• Knowledge of following regulatory submission applications preferred:
 Lorenz Docubridge
 InSight for Publishing/Viewing
 Veeva Vault RIMS (Regulatory information Management System)

Key Words (for sourcing):
• Pharma or/and Biotech, Regulatory Affairs
• Regulatory Submissions