Senior Specialist, Regulatory Operations

Summit Therapeutics, Inc.

. Provide hands-on technical preparation and publishing of regulatory submissions, including eCTD packages .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $122,000 - $143,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, including eCTD publishing and document preparation, while ensuring compliance with FDA and ICH standards. Proficient in managing submission workflows and maintaining accurate records within Veeva RIM and comparable systems.

Highest-signal resume keywords

Regulatory Operations ExperienceECTD PublishingDocument PreparationVeeva RIMTechnical Quality Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ECTD Lifecycle ManagementDocument FormattingPDF PreparationTechnical QCSubmission SupportMetadata ManagementSubmission TrackingDocument ConversionTroubleshootingAction Tracking

Soft Skills

Organizational SkillsCommunication SkillsRisk ManagementIndependent Work

Tools & Technologies

Veeva RIMAdobe AcrobatMicrosoft WordVeeva PromoMats

Certifications & Qualifications

Bachelor's Degree in Life SciencesMaster's in Regulatory Affairs

Industry Keywords

Regulatory SubmissionsPharmaceuticalBiotechnologyFDA StandardsICH Standards

About the role

Key responsibilities & impact

Provide hands-on technical preparation and publishing of regulatory submissions, including eCTD packages
Support submissions to assigned health authorities
Manage operational execution of assigned routine submissions
Support larger or complex filings under another Regulatory Operations Submission Manager
Maintain submission plans, content trackers, deliverable dates, and readiness status
Follow up with Document Owners on handoffs, document status, and open actions; provide updates and escalate risks
Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarks, hyperlinks, and technical checks
Compile, publish, and validate eCTD and non-eCTD packages using approved tools and current regional specifications
Perform document-level and, when qualified, submission-level technical quality control
Confirm technical readiness, transmit or deliver submissions after authorization, track acknowledgments, resolve technical rejections, and archive final records
Maintain application, regulatory objective, submission, document, metadata, milestone, and Health Authority correspondence records in Veeva RIM
Support workflows, data quality, user issue triage, and assigned system changes with RIM, IT, and Quality stakeholders
Provide technical support for promotional submissions, including Form FDA 2253, when assigned
Support submission-related projects through action tracking, meeting follow-up, and status reporting
Participate in RIM migration, user acceptance testing, training, work instruction updates, and process improvements
Perform other related duties as assigned

Requirements

What you’ll need

Bachelor's degree in life sciences or a related discipline
Minimum of 4 years of Regulatory Operations experience in pharmaceutical or biotechnology
Hands-on document preparation, eCTD publishing, and submission support experience
Working knowledge of eCTD lifecycle management, applicable FDA and ICH technical standards, publishing validation, and document- and submission-level technical QC
Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation, bookmarking, hyperlinking, and troubleshooting
Experience using a RIM or comparable validated document and submission management system, with attention to accurate metadata and records
Ability to organize concurrent deliverables, follow up across functions, communicate risks promptly, and work independently within assigned responsibilities
Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content workflow (preferred)
Experience supporting submissions outside the United States or preparing Form FDA 2253 and postapproval submissions (preferred)
Experience with system migration, user acceptance testing, work instructions, or submission project tracking (preferred)
Master’s in Regulatory Affairs highly desired

Benefits

Comp & perks

Total compensation package may include bonus
Stock
Benefits
Other applicable variable compensation