New · posted Oct 24
Summit Therapeutics · Biotechnology
Senior Specialist, Regulatory Operations
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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.
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.
What you need
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 Qualificationsnice to have
- 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
Pay Transparency
$122,000—$143,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
What you'll do
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.
Pay and benefits
$122,000 – $143,000 a year
Employer providedBonus
Stock
Benefits package
From the posting
About Summit Therapeutics
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:
Equal opportunity, accessibility and legal noticesSummit Therapeutics's statements, word for word
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Job intelligence
The context around this role
Live data · October 25, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Senior & Principal roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $122,000 | — | $143,000 |
| All US (middle half) | $122,000 | $123,500 | $123,500 |
This role: Summit Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 25, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 41 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Summit Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions14
- Documentation and SOPs10
- Collaboration and leadership8
- Data and digital systems4
- Validation and qualification3
- Lab testing and methods2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Summit Therapeutics on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 3
- Locations
By discipline
- Regulatory5 71%
- Quality2 29%
By level
- Director4 57%
- Manager2 29%
- Senior & Principal1 14%
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Senior Specialist, Regulatory Operations at Summit Therapeutics
Open until filled. $122K–$143K a year, employer provided.