Regulatory Systems Manager

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

May 19, 2025 - 15:10

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