Regulatory Systems Manager

Job Summary

A company is looking for a Regulatory Systems Manager (RIM/eCTD) to support global regulatory operations.

Key Responsibilities

• Support eCTD submissions across global development and lifecycle programs
• Provide oversight of outsourced publishing activities and lead drafting/review of process documents
• Conduct end-user training and systems support while ensuring alignment with global Health Authority tech guidelines

Required Qualifications

• 3+ years of experience supporting regulatory submissions for the US and EU with knowledge of eCTD processes
• Proficiency with regulatory systems such as Veeva, InSight, Docubridge, or CARA
• Experience in drafting process documents, conducting UAT testing, and collaborating with global IT teams
• Experience overseeing publishing vendors