Associate 1 - Regulatory Affairs

The Associate supports Regulatory leadership in development and execution of global nonclinical and clinical regulatory strategies, preparing for health authority interactions and supporting regulatory submissions. The Associate works with internal cross functional study team members and external parties (e.g., health authorities, vendors, and consultants) to maintain up-to-date information on regulatory requirements and submissions.

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• 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, including briefing materials, responses, and follow-up documentation
• Coordinates with clinical research organizations and other external partners supporting global regulatory submissions and health authority correspondence
• Collaborates with nonclinical, clinical, and other cross-functional teams to collect and compile documents for global regulatory submissions
• Collaborates with Regulatory Operations to provide final documents and performs quality-control reviews of published submission outputs
• Supports the submission and maintenance of investigational new drug applications and clinical trial applications
• Supports the maintenance of marketed product applications (i.e., NDAs and MAAs)
• Supports regulatory reporting requirements for investigational and marketed products
• Tracks regulatory submission timelines, deliverables, and health authority commitments
• Maintains current knowledge of applicable regulatory requirements and performs assigned activities in accordance with company procedures and applicable regulations

Preferred Skills, Qualifications and Technical Proficiencies:

• 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 while meeting established timelines and quality expectations
• Ability to work effectively both as a collaborative team member and as an individual contributor, with appropriate guidance

Preferred Education and Experience:

• Bachelor’s degree required. Advanced degree (M.S., Pharm.D., Ph.D.) in life sciences (including chemistry, molecular biology, or similar) preferred
• Minimum of 1-2 years of clinical regulatory experience

The pay range that the Company reasonably expects to pay for this headquarters-based position is $84,400 – $99,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.