Senior Regulatory Submissions Specialist

OpenKrill; United States; Remote; USD 122,000 - 143,000; Full time

Job summary

Summit Therapeutics Inc. seeks a Senior Specialist, Regulatory Operations to lead hands-on preparation and publishing of regulatory submissions, including eCTD packages, for INDs, CTAs, and health authority responses.

The role requires 4+ years in Regulatory Operations, strong knowledge of FDA/ICH standards, and experience with Veeva RIM or PromoMats. Excellent document formatting and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in life sciences or related discipline.
• Master's in Regulatory Affairs highly desired.
• Minimum 4 years of Regulatory Operations experience in pharmaceutical/biotech.
• Working knowledge of eCTD lifecycle, FDA/ICH standards, publishing validation, and QC.

Responsibilities

• Serve as the assigned RSM for routine IND, CTA, lifecycle submissions and Health Authority responses.
• Maintain submission plans, content trackers, deliverable dates and readiness status.
• Prepare submission-ready Word and PDF documents with formatting and linked content.
• Publish and validate eCTD and non-eCTD packages; perform document QC and resolve findings.

Skills

Regulatory operations

eCTD publishing

FDA/ICH standards

RIM systems

Document formatting

Education

Bachelor's degree in life sciences

Master's in Regulatory Affairs

Tools

Veeva RIM

PromoMats

Job description

Summit Therapeutics Inc. seeks a Senior Specialist, Regulatory Operations to lead hands-on preparation and publishing of regulatory submissions, including eCTD packages, for INDs, CTAs, and health authority responses.

The role requires 4+ years in Regulatory Operations, strong knowledge of FDA/ICH standards, and experience with Veeva RIM or PromoMats. Excellent document formatting and cross-functional collaboration are essential.