Manager - Senior Manager, Regulatory Operations

2 days ago

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Cogent Biosciences

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Precision therapeutics for genetically defined diseases. Real solutions for real challenges.

gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors

51 - 200

Description

•Supports Regulatory Affairs with managing IND lifecycle submissions, including scheduling and tracking •Assist with developing systems and processes to prepare Cogent for an NDA, label approval and commercialization •Assist with formatting and publishing eCTD compliant documents •Processes and publishes safety reports and coordinates with CRO for agency submission •Works extensively with Veeva software, including RIM data entry •Assist with Veeva change controls and Veeva maintenance •Trains new hires and employees on Veeva •Assist with writing and maintaining SOPs •Communicates with and advises development teams on publishing requirements, as well as maintaining focus and awareness of potential delays, problems, gaps of information, expectations, project steps, milestones and deliverables •Has thorough understanding of domestic and international regulations and guidelines and can interpret the intent of the regulations and guidelines •Proactively and independently researches and communicates potential Regulatory Operations issues that could streamline the development process and projects

Requirements

•BA/BS or equivalent experience •10 years’ experience in Regulatory Operations publishing or equivalent in biotech, pharma, or medical device •10 years’ experience with RIMs and electronic submission software •Must be “hands-on”, willing and expected to take on projects and tasks to support the team •Solid understanding of the processes and interactions essential to produce regulatory submissions