Senior Manager, Regulatory Operations

March 21

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

💵 $153k - $180k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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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 Senior Manager, Regulatory Operations is responsible for assisting with project oversight of complex submissions, including formatting and publishing electronic documents, ensuring global regulatory submissions are of highest quality and delivered on time. • This 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.

🎯 Requirements

• Bachelor's degree in life sciences or a related discipline required • A minimum of 7 years of regulatory operations experience, including preparation, publishing, and submissions for INDs, BLAs/NDAs, and CTAs in pharmaceutical, biotechnology, or life sciences industry experience • Strong expertise with electronic publishing tools for regulatory submissions (experience with Lorenz docuBridge) • 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) • Knowledge of applicable FDA, HC, EU, and ICH guidelines related to regulatory submissions, clinical trials, and marketing applications • Strong computer and database skills