Senior Specialist, Regulatory Operations

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $122k - $143k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• 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

• 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

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