Director, Regulatory Affairs
Eikon Therapeutics(2 days ago)
About this role
Eikon Therapeutics is seeking a seasoned Director of Regulatory Affairs to guide and execute regulatory strategies across clinical development programs. The role involves providing regulatory guidance, ensuring compliance with FDA and international requirements, and collaborating with cross-functional teams to support drug development and approval processes.
Required Skills
- Regulatory Affairs
- FDA
- IND
- NDAs
- Regulatory Strategy
- Clinical Development
- Submission Management
- Compliance
- Cross-Functional Collaboration
- Quality Systems
Qualifications
- Post-graduate degree with 10+ years of relevant experience, or a Bachelor’s degree with 12+ years of experience
About Eikon Therapeutics
eikontx.comEikon Therapeutics is a biotechnology company that advances breakthrough therapeutics through the purposeful integration of science and engineering. The company has built a proprietary discovery platform that combines high‑resolution structural and single‑particle imaging (including cryo‑EM), automated experimental engineering, and computational/AI methods to map protein conformational landscapes and identify novel small‑molecule modulators. That platform is used to accelerate target identification, structure‑enabled design, and lead optimization across multiple therapeutic areas through internal programs and external partnerships. Headquartered in Cambridge, MA, Eikon emphasizes an engineering‑first approach to tackle challenging protein targets and shorten drug discovery timelines.
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