Cogent Biosciences
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. With a commitment to advancing best-in-class small molecule therapeutics, Cogent aims to tackle diseases with clear genetic mutations as their cause. Their work is driven by a dedication to improve human health by designing rational precision therapies that address critical unmet medical needs. The company operates with a focus on diseases such as systemic mastocytosis, for which they are currently developing and advancing therapeutics like bezuclastinib. Cogent Biosciences highlights their commitment to transforming patient lives through innovative scientific approaches and robust clinical trials.
gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors
Associate Director - Regulatory Affairs
February 19
Cogent Biosciences
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. With a commitment to advancing best-in-class small molecule therapeutics, Cogent aims to tackle diseases with clear genetic mutations as their cause. Their work is driven by a dedication to improve human health by designing rational precision therapies that address critical unmet medical needs. The company operates with a focus on diseases such as systemic mastocytosis, for which they are currently developing and advancing therapeutics like bezuclastinib. Cogent Biosciences highlights their commitment to transforming patient lives through innovative scientific approaches and robust clinical trials.
gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors
📋 Description
• The Senior Manager/Associate Director of Regulatory Affairs will assist in the development and implementation of regulatory strategies to advance Cogent’s precision kinase inhibitors in oncology and rare diseases. • This individual will provide strategic input and regulatory support to cross-functional development teams. • Working alongside senior Regulatory staff, this individual will be a key contributor to Cogent’s project and regulatory teams.
🎯 Requirements
• At least 4 years of experience in Regulatory Affairs • Regulatory filing experience (e.g, INDs, CTAs, NDAs, MAAs or equivalent) • Experience in rare disease and oncology • Solid working knowledge of drug development processes and US regulatory requirements required; knowledge of EU, UK, Canada, ROW regulatory requirements is preferred • Strong project management skills, with a track record of delivering high impact results • Outstanding and versatile written and oral communication skills • Bachelor’s degree required. Advanced degree in a Life Science or related discipline preferred
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