Vice President, Regulatory Affairs

Job Description
Edison Pharmaceuticals, Inc. is a privately-held specialty pharmaceutical company focused on the design, discovery, translation, and development of orally available redox-based drugs targeting rare orphan inherited mitochondrial respiratory chain diseases. Edison is in phase 2 clinical development with EPI-743 for the treatment of inherited respiratory chain disorders.

We are looking for a seasoned regulatory strategist - an MD/PhD/JD - who has successfully shepherded first-in-class drugs for clinical indications without approved therapies through the regulatory process to approval and marketing. The VP Regulatory Affairs will be responsible for developing the company’s overall regulatory strategy, manage the relevant tasks to direct the company towards regulatory approval, and maintain regulatory compliance for R&D and commercial activities.

Requirements
• MD/PhD/JD with 15+ years experience in biotechnology and/or pharmaceutical industry;
• Track record of successful drug approvals in the US and EU with an emphasis on first-in-class drugs for rare diseases;
• Strategic thinker with proven ability to collaborate with FDA/EMA on non-standard regulatory pathways to drug approval;
• Proven ability to utilize available regulatory policies such as fast track and breakthrough to optimize regulatory timelines;
• Experience in advancing pediatric therapies through FDA and EMA process;
• Consummate flexible team player with hands-on attitude

Company

Edison Pharmaceuticals

Job Code

State or Province

California

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