Director, Regulatory Operations

5 days ago

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Summit Therapeutics, Inc.

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Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

Oncology • Clinical Trials • Health Care

51 - 200 employees

Founded 2003

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Director, Regulatory Operations is responsible for project oversight of complex submissions formatting and publishing electronic documents and ensuring global regulatory submissions are of highest quality and delivered on time. • This leadership role will drive regulatory submission excellence, process optimization, and system innovation, ensuring the timely execution of regulatory filings across multiple health authorities, including FDA, EMA, Health Canada, PMDA, and other global agencies. • Provide strategic leadership and oversight of the global regulatory submission function, ensuring high operational and compliance standards. • Develop and execute submission strategies for INDs, BLAs, CTAs, and post-approval submissions. • Prepare high-quality electronic regulatory dossiers (eCTD) according to health authority requirements and guidance, including publishing and submission of dossiers. • Serve as Lorenz docuBridge subject matter expert to ensure optimization. • Independently perform document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications, including troubleshooting issues and identifying solutions. • Perform quality control checks and work with the subject matter expert to address findings. • Identify issues during document formatting and/or publishing and liaise with subject matter expert to implement resolutions. • All other duties as assigned.

🎯 Requirements

• Bachelor's degree in life sciences or a related discipline required • A minimum of 10+ years of pharmaceutical, biotechnology, or life sciences industry experience, including preparation, publishing, and submissions for INDs, BLAs/NDAs, and CTAs • Prior experience managing a regulatory operations team • Strong expertise with electronic publishing tools for regulatory submissions (experience with Lorenz docuBridge) • Strong knowledge of applicable FDA, HC, EU, and ICH guidelines related to regulatory submissions, clinical trials, and marketing applications • Strong expertise with document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications • Experience with project managing complex submissions • Proficient knowledge of and experience with electronic publishing tools for regulatory submissions (experience with Lorenz docuBridge a strong plus) • Expert knowledge of eCTD submission requirements and lifecycle management of eCTD submissions • Attention to detail, accuracy, and confidentiality • Clear and concise oral and written communication skills • Excellent organizational skills • Critical thinking, problem solving, ability to work independently • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. • Communicate effectively and articulate complex ideas in an easily understandable way. • Proficient in using MS Office Suite, Adobe Acrobat and ISIToolBox, SharePoint, EndNote, Accenture StartingPoint templates, and other relevant tools • Experience with document formatting (Word and PDF) • Strong computer and database skills