Associate I, Regulatory Affairs

The role

The Associate supports Regulatory leadership in the development and execution of global nonclinical and clinical regulatory strategies. This person prepares for health authority interactions and supports regulatory submissions.

What you will do

• Participates in cross-functional teams supporting clinical studies to develop Corcept products
• Assists with the preparation, review, and submission of regulatory documents
• Supports preparation for health authority interactions and meetings
• Coordinates with clinical research organizations and other external partners
• Collaborates with nonclinical, clinical, and other cross-functional teams to collect and compile documents
• Collaborates with Regulatory Operations to provide final documents and performs quality-control reviews
• Supports the submission and maintenance of investigational new drug applications and clinical trial applications
• Supports the maintenance of marketed product applications
• Supports regulatory reporting requirements for investigational and marketed products
• Tracks regulatory submission timelines, deliverables, and health authority commitments

Required qualifications

• Bachelor’s degree
• Minimum of 1-2 years of clinical regulatory experience
• Must be currently authorized to work in the United States on a full-time basis

Nice to have

• Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar)
• Strong interpersonal and communication skills
• Demonstrates initiative and proactively supports project and team needs
• Adapts to changing priorities and contributes to practical, solution-oriented problem-solving
• Ability to organize and manage multiple assignments from different stakeholders
• Ability to work effectively both as a collaborative team member and as an individual contributor

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.