Remote Senior Regulatory Operations Specialist

Summit-Therapeutics

Miami (FL)

Remote

USD 122,000 - 143,000

Full time

4 days ago

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Job summary

Summit Therapeutics Inc. is seeking a Senior Specialist, Regulatory Operations to lead hands-on preparation and publishing of regulatory submissions, including eCTD packages, for IND/CTA filings and health authority requests.

This is a remote (US) role with responsibilities spanning submission planning, content readiness, and cross-functional coordination. You will maintain accurate Veeva RIM records, support submission-related projects, perform document QC, and ensure timely delivery of

Qualifications

Bachelor's degree in life sciences or related field; Master’s in Regulatory Affairs preferred.
Minimum of 4 years in Regulatory Operations with eCTD publishing and submission support.
Knowledge of eCTD lifecycle, FDA/ICH standards, publishing validation, and QC.
Strong Word and Adobe Acrobat skills with bookmarking/hyperlinking.
Experience with a RIM system and metadata management.

Responsibilities

Serve as assigned RSM for routine submissions (IND, CTA) and complex filings under supervision.
Maintain submission plans, content trackers, deliverable dates, and readiness status with Regulatory Lead and project team.
Prepare submission-ready Word and PDF documents, including formatting, bookmarks, and hyperlinks.
Compile, publish, and validate eCTD/non-eCTD packages and perform document-level QC.
Provide submission-level QC and track delivery status; archive final records.