Description

You will manage and support regulatory submission applications within a Biotech or Pharmaceutical environment.

Responsibilities

• Provide L2/L3 support for service requests, incident resolution, and release management.
• Implement minor enhancements for regulatory submission applications.
• Execute Computer System Validation activities and author necessary documentation.
• Manage workflows related to Regulatory Affairs and Health Authority interactions.

Required Skills

• 5+ years of experience in IT support within the Pharma or Biotech industries.
• Direct experience with R&D IT support functions.
• Practical knowledge of ITIL frameworks, specifically Incident, Change, Knowledge, and Problem Management.
• Understanding of Regulatory Information Management System (RIMS) administration.
• Familiarity with Regulatory Submission processes and workflows for FDA and EMA.
• Proficiency with Windows Server.
• Experience with Documentum.
• Working knowledge of DQL/SQL.
• Bachelor's degree or equivalent graduate qualification.

Preferred Skills

• Experience with Lorenz Docubridge.
• Experience with InSight for Publishing/Viewing.
• Experience with Veeva Vault RIMs.

Key Skills

Education

Any Graduate