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
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.
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.
Skills Required
- Bachelor’s degree in life sciences or a related discipline
- At least 4 years of Regulatory Operations experience in pharmaceutical or biotechnology
- Hands-on experience with document preparation, eCTD publishing, and submission support
- Working knowledge of eCTD lifecycle management and applicable FDA and ICH technical standards
- Experience with publishing validation and document- and submission-level technical quality control
- 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
- Ability to organize concurrent deliverables, coordinate across functions, communicate risks, and work independently
- Master’s degree in Regulatory Affairs
- Experience with Veeva RIM, Veeva PromoMats, or comparable promotional content workflow
- Experience supporting submissions outside the United States, Form FDA 2253, or postapproval submissions
- Experience with system migration, user acceptance testing, work instructions, or submission project tracking
What We Do
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
