Associate Director, Regulatory Affairs

Corcept Therapeutics seeks an Associate Director of Regulatory Affairs to lead domestic and international regulatory strategy, submissions, and health authority interactions. The role involves coordinating cross-functional teams, maintaining compliance with regulatory requirements, and managing product lifecycle activities in a hybrid position based in Redwood City, California.

Responsibilities

• Provide leadership to regulatory team and oversee departmental strategic initiatives
• Manage company interactions with FDA and international health authorities
• Develop and execute regulatory strategies supporting product approvals and lifecycle management
• Lead preparation, review, and submission of regulatory documents for new and existing products
• Partner cross-functionally with Clinical Operations, Quality, and Development to advance programs

Requirements

• Bachelor's degree; advanced degree (M.S., Pharm.D., M.D., or J.D.) preferred
• Strong analytical and problem-solving capabilities
• Excellent written and verbal communication skills with influencing ability
• Demonstrated attention to detail and organizational accuracy
• Experience managing multiple concurrent projects from diverse stakeholders
• Knowledge of U.S. and international regulatory requirements and guidelines