Associate Director, Regulatory Affairs

The role

The Associate Director partners with regulatory leadership to obtain and maintain regulatory filings and registrations for domestic and international regions. This role coordinates activities with internal team members and external parties to maintain information on regulatory requirements and product submissions.

What you will do

• Provides team and department leadership
• Manages the company's interactions with domestic and international health authorities
• Develops and executes regulatory strategies to support product approval and lifecycle management
• Leads the preparation, review, and submission of regulatory documents for new products and changes to existing applications
• Maintains current knowledge of U.S. and international regulatory requirements and guidelines
• Partners cross-functionally with Clinical Operations, Clinical Development, Quality, and other functions
• Collaborates with clinical teams to ensure regulatory submissions and clinical presentations are accurate and supported by data
• Provides guidance, coaching, and subject-matter expertise to colleagues
• Oversees regulatory reporting requirements for investigational products
• Manages preparation for, participation in, and follow-up to meetings with FDA and other global health authorities

Required qualifications

• Minimum of 7 years of relevant regulatory experience

Nice to have

• Strong analytical and problem-solving skills
• Strong written and verbal communication skills
• Strong attention to detail
• Ability to balance and manage multiple projects from multiple stakeholders
• Bachelor's degree
• Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar)

About the company

Corcept is focused on the science of cortisol. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists.