Description

Act as the subject matter expert for regulatory information management systems within the vaccines and biologics space.

Responsibilities

• Collect and document user, functional, and technical requirements for regulatory systems.
• Manage application configuration changes following IT Change Management and GxP Change Control procedures.
• Participate in system validation, release, and post-deployment support activities with Quality and IT Operations.
• Troubleshoot technical issues and provide application support and training to end users.
• Evaluate opportunities for process and technology improvements and contribute to business cases.

Required Skills

• Minimum of 5 years of experience working with regulatory information systems.
• Practical understanding and application of cGMPs in relation to regulatory processes.
• Proficiency in SDLC principles and industry best practices.
• Experience with Business Analysis and Data Migration.
• Technical proficiency in PL/Transact SQL and XML.
• Strong problem-solving, troubleshooting, and communication skills.
• Bachelor's degree in Information Technology, Biological Science, or a related field.

Preferred Skills

• Expertise in Computer System Validation (CSV), GAMP5, Content Management, or object-oriented design.
• Experience with regulatory solutions such as Veeva RIMS, Lorenz docuBridge, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, or ISIToolbox.
• Project management experience and IT-related certifications.

Key Skills

Education

Not specified