Senior Specialist, Regulatory Operations

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

• Non-small Cell Lung Cancer (NSCLC)
• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
• Colorectal Cancer (CRC)
• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

The Senior Specialist, Regulatory Operations provides hands-on technical preparation and publishing of regulatory submissions, including eCTD packages, and supports submissions to assigned health authorities. The role manages the operational execution of assigned routine submissions and supports larger or complex filings under another Regulatory Operations Submission Manager (RSM).

This position also prepares submission-ready documents, follows up on content readiness and milestones, maintains accurate Veeva RIM records, and supports submission-related projects and system activities.

Role and Responsibilities:

Submission preparation and execution

Serve as the assigned RSM for routine IND, CTA, application lifecycle, meeting, and Health Authority response submissions. Support complex or high-priority filings under the direction of the assigned RSM.

Maintain assigned submission plans, content trackers, deliverable dates, and readiness status with the Regulatory Lead and project team. Follow up with Document Owners on expected handoffs, document status, and open actions; provide updates and escalate risks to the Regulatory Lead and, when applicable, the lead RSM.

Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarks, hyperlinks, and technical checks. Identify content changes needed after handoff and route them to the Document Owner and Regulatory Lead for review and reapproval.

Compile, publish, and validate eCTD and non-eCTD packages using approved tools and current regional specifications. Perform document-level technical QC, resolve publishing or validation findings with responsible stakeholders, and support global submission delivery as assigned.

When qualified and independent of package preparation, perform submission-level QC for packages prepared by others. For assigned submissions, confirm technical readiness, transmit or deliver only after Regulatory Lead authorization, track acknowledgments or delivery status, resolve technical rejections, and archive final records.

RIM and cross-functional support

Create and maintain accurate 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 in coordination with the RIM business owner, IT, and Quality.

Provide technical support for promotional submissions, including Form FDA 2253, when assigned. Coordinate with the Regulatory Lead, promotional content owners, and PromoMats users to obtain approved versions and required package materials.

Support submission-related projects through action tracking, meeting follow-up, and status reporting. Participate in assigned RIM migration, user acceptance testing, training, work instruction updates, and process improvements; perform other related duties as assigned.

Required Qualifications

Bachelor's degree in life sciences or a related discipline. Master’s in Regulatory Affairs Highly Desired.

A minimum of 4 years of Regulatory Operations experience in pharmaceutical or biotechnology, including hands-on document preparation, eCTD publishing, and submission support.

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.

Preferred Qualifications

• Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content workflow.
• Experience supporting submissions outside the United States or preparing Form FDA 2253 and postapproval submissions.
• Experience with system migration, user acceptance testing, work instructions, or submission project tracking.
• This is the pay for this position