Associate I, Regulatory Affairs

Corcept Therapeutics•Redwood City, CA

1d•$84,400 - $99,300•Hybrid

About The Position

The Associate supports Regulatory leadership in developing and executing global nonclinical and clinical regulatory strategies, preparing for health authority interactions, and supporting regulatory submissions. The role works with internal cross-functional study teams and external parties, including health authorities, vendors, and consultants, to maintain current information on regulatory requirements and submissions. This is a hybrid role that typically requires on-site presence three days per week. The position is based at the company headquarters.

Requirements

Bachelor’s degree required.
Minimum of 1–2 years of clinical regulatory experience.
Strong interpersonal and communication skills.
Demonstrated initiative and proactive support for project and team needs.
Ability to adapt to changing priorities and contribute 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.
Must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

Advanced degree (M.S., Pharm.D., or Ph.D.) in life sciences, including chemistry, molecular biology, or a similar field.

Responsibilities

Participate in cross-functional teams supporting clinical studies to develop Corcept products.
Assist with the preparation, review, and submission of regulatory documents.
Support preparation for health authority interactions and meetings, including briefing materials, responses, and follow-up documentation.
Coordinate with clinical research organizations and other external partners supporting global regulatory submissions and health authority correspondence.
Collaborate with nonclinical, clinical, and other cross-functional teams to collect and compile documents for global regulatory submissions.
Collaborate with Regulatory Operations to provide final documents and perform quality-control reviews of published submission outputs.
Support the submission and maintenance of investigational new drug applications and clinical trial applications.
Support maintenance of marketed product applications, including NDAs and MAAs.
Support regulatory reporting requirements for investigational and marketed products.
Track regulatory submission timelines, deliverables, and health authority commitments.
Maintain current knowledge of applicable regulatory requirements and perform assigned activities in accordance with company procedures and applicable regulations.