Remote Senior Regulatory Operations Specialist

Summit Therapeutics

United States

Remote

USD 122,000 - 143,000

Full time

5 days ago

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Job summary

Summit Therapeutics Inc. is seeking a Senior Specialist, Regulatory Operations to perform hands-on preparation and publishing of regulatory submissions, including eCTD packages, for US and global health authorities.

You will maintain submission plans, track milestones, and ensure content readiness, while managing Veeva RIM records and coordinating with cross-functional teams. Remote role in the US; includes opportunities to contribute to multiple Phase studies and ensure compliance with FDA and

Qualifications

Bachelor's degree in life sciences or a related discipline.
Master’s in Regulatory Affairs is highly desired.
Minimum of 4 years in Regulatory Operations with hands-on document preparation and eCTD publishing.
Strong Word and Adobe Acrobat skills including bookmarking and hyperlinks.
Experience using a RIM or equivalent submission management system.

Responsibilities

Prepare and publish regulatory submissions (eCTD and non-eCTD) and ensure readiness.
Maintain submission plans, trackers, and milestones with Regulatory Lead.
Create submission-ready documents with formatting, bookmarks and links.
Publish and validate eCTD packages; support global submissions and QC findings.
Maintain accurate Veeva RIM records and coordinate with cross-functional teams.
Support promotional submissions including Form FDA 2253 as needed.