Global Regulatory Submissions Specialist

Summit Therapeutics, Inc.; United States; On-site; USD 122,000 - 143,000; Full time

Job summary

Summit Therapeutics Inc. in the United States seeks a Senior Specialist, Regulatory Operations to lead hands-on preparation and publishing of regulatory submissions, including eCTD packages, and to support submissions to health authorities.

You will manage submission plans, content readiness, and maintain accurate Veeva RIM records, coordinating with Regulatory Lead and project teams on routine IND/CTA filings and more complex submissions.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Master’s in Regulatory Affairs highly desired.
• Minimum 4 years of Regulatory Operations experience with hands-on document preparation and eCTD publishing.
• Strong understanding of FDA/ICH standards and QC.
• Experience with RIM systems and metadata management.
• Proficient in Word and Adobe Acrobat, including bookmarking and hyperlinks.
• Ability to manage multiple deliverables and communicate risks.

Responsibilities

• Serve as the assigned RSM for routine IND, CTA, and Health Authority submissions.
• Maintain submission plans, content trackers, and readiness status with Regulatory Lead.
• Prepare submission-ready Word and PDF documents with formatting and checks.
• Publish and validate eCTD and non-eCTD packages and perform QC.
• Perform submission-level QC and coordinate delivery with Regulatory Lead; archive records.
• Create and maintain RIM records in Veeva and support workflows.
• Provide technical support for promotional submissions (FDA Form 2253) when assigned.
• Support submission-related projects through tracking, meetings, and status reporting.
• Contribute to RIM migration, UAT, and process improvements.

Skills

Attention to detail

Project coordination

Communication skills

Independent working

Education

Bachelor's degree in life sciences or related discipline

Master’s in Regulatory Affairs

Tools

Microsoft Word

Adobe Acrobat

RIM system

Veeva RIM

Veeva PromoMats

Job description

Summit Therapeutics Inc. in the United States seeks a Senior Specialist, Regulatory Operations to lead hands-on preparation and publishing of regulatory submissions, including eCTD packages, and to support submissions to health authorities.

You will manage submission plans, content readiness, and maintain accurate Veeva RIM records, coordinating with Regulatory Lead and project teams on routine IND/CTA filings and more complex submissions.